|
FDA Warning Letters indexed by Company Names
Link:
Pharm/Biotech Resources
21st Century Sports Nutritionals, Inc.
- 21st Century Sports
Nutritionals, Inc. (Phenylkinetics, Libido Magic)
2bbrands.com/drugstore
-
2bbrands.com/drugstore (Accutane)
3M Pharmaceuticals
-
3M
Pharmaceuticals (MaxairTMAutohalerTM (pirbuterol
acetate inhalation aerosol))
-
3M
Pharmaceuticals (Tambocor (flecainide acetate) Tablets)
Abbott
Laboratories
-
Abbott
Laboratories (Depakote (divalproex sodium))
-
Abbott
Laboratories (HUMIRA (adalimumab) Injection)
-
Abbott
Laboratories (Survanta®(beractant) intratracheal suspension)
-
Abbott
Laboratories (Kaletra (lopinavir/ritonavir) Capsules and Oral
Suspension)
-
Abbott
Laboratories (Norvir (ritonavir capsules) Soft Gelatin)
-
Abbott
Laboratories (Mivacron (mivacurium chloride) Injection)
ACS Dobfar
- ACS Dobfar
(Site Inspection)
Actelion Pharmaceuticals US, Inc.
- Actelion
Pharmaceuticals US, Inc. (Tracleer® (bosentan) Tablets)
- Actelion
Pharmaceuticals US, Inc. (Tracleer (bosentan) Tablets)
-
Actelion Pharmaceuticals US, Inc. (Tracleer (bosentan) Tablets)
Aerosol Science Laboratories, Inc.
-
Aerosol Science Laboratories, Inc. (SINUS SCIENCE Aerosol Medication
Delivery System)
Alaven Pharmaceutical LLC
- Alaven
Pharmaceutical LLC (Rowasa® (mesalamine) Rectal Suspension Enema)
Alcon Research/Alcon
Laboratories
-
Alcon
Laboratories, Inc. (Ciprodex (ciprofloxacin) sterile otic suspension)
-
Alcon
Research, Inc. (NevanacTM (nepafenac ophthalmic suspension) 0.1%)
-
Alcon
Research, Ltd. (Travatan® (travoprost ophthalmic solution) 0.004%)
-
Alcon
Laboratories, Inc. (CIPRO HC Otic)
-
Alcon
Research Ltd. (Cipro HC Otic Suspension and Ciloxan)
-
Alcon
Research Ltd.(Patanol (olopatadine hydrochloride ophthalmic solution)
0.1%)
-
Alcon
Laboratories (Ciloxan (ciprofloxacin HCL) Ophthalmic Solution)
Aliachem A.S.
- Aliachem
A.S. (API Site Inspection)
Allergan, Inc.
-
Allergan,
Inc. (LATISSETM (bimatoprost ophthalmic solution) 0.03%)
-
Allergan,
Inc. (ACZONE® (dapsone) Gel, 5%)
-
Allergan,
Inc. (ACULAR LS® (ketorolac tromethamine ophthalmic solution) 0.4%)
-
Allergan,
Inc. (Lumigan (bimatoprost ophthalmic solution) 0.03%)
-
Allergan, Inc.
(Lumigan (bimatoprost ophthalmic solution) 0.03%)
-
Allergan,
Inc. (Alphagan (brimonidine tartrate ophthalmic solution) 0.2%)
-
Allergan
Inc. (Azelex (Azelaic Acid) 20% Cream)
-
Allergan,
Inc. (Alocril (nedocromil sodium ophthalmic solution), 2%)
Allergy, Asthma & Immunology Associates of
Terra Haute
-
Allergy, Asthma & Immunology Associates of Terra Haute (Clinical
Investigation)
Alza
Corporation
-
Alza
Corporation (Viadur® (leuprolide acetate implant))
-
Alza
Corporation (Ditropan XL® (oxybutynin chloride) Extended-Release Tablets)
-
Alza
Corporation (Doxil® (doxorubicin HCL liposome injection))
-
Alza
Corporation (Ditropan® XL (oxybutynin chloride) Extended Release
Tablets)
-
Alza
Corporation (Ditropan XL (oxybutynin chloride) Extended Release
Tablets)
-
Alza
Corporation (Doxil® (doxorubicin HCl liposome injection))
American Regent
Laboratories, Inc.
- American Regent
Laboratories, Inc. (Venofer (Iron Sucrose Injection))
Ames Periodontal Specialists
-
Ames Periodontal Specialists (BMIS Inspection)
Amgen, Inc.
- Amgen, Inc.
(SENSIPAR® (cinacalcet HCl) Tablets)
- Amgen, Inc.
(Enbrels (etanercept))
Amrita Aromatherapy, Inc.
-
Amrita Aromatherapy, Inc. (Unapproved/Uncleared/Unauthorized Products
Related to the H1N1 Flu Virus)
Amylin Pharmaceuticals, Inc.
- Amylin
Pharmaceuticals, Inc. (Byetta® (exenatide) injection)
Antibioticos do Brasil Uda
-
Antibioticos do Brasil Uda (CGMP/Adulterated)
The
Asthma and Allergy Institute
-
The
Asthma and Allergy Institute (Clinical Study Inspection)
Ashland Drug
-
Ashland Drug (Nicotine Lollipops)
Astellas Pharma US, Inc.
-
Astellas Pharma US, Inc. (Prograf (tacrolimus capsules and injection))
AstraZeneca
-
AstraZeneca (Seroquel (quetiapine fumarate))
-
AstraZeneca (Seroquel® (quetiapine fumarate) Tablets)
-
AstraZeneca (Crestor®(rosuvastatin calcium) Tablets)
-
AstraZeneca (Crestor® (rosuvastatin calcium) Tablets)
-
AstraZeneca (Merrem I.V. (meropenem for injection))
-
AstraZeneca
(Nolvadex® (tamoxifen citrate) Tablets)
-
AstraZeneca
(Zomig© (zolmitriptan) Tablets, 2.5 mg and 5 mg)
-
AstraZeneca
(IND No: ZD1839, ZD0473, ZD1694, ZD9238, & Arimidex (ansastrozole) tablets)
-
AstraZeneca
(Diprivan (propofol) Injectable Emulsion)
-
AstraZeneca (Nolvadex®
(tamoxifen citrate))
-
AstraZeneca (Prilosec
(omeprazole) Delayed-Release Capsules)
-
AstraZeneca L.P.
(Accolate (zafirkulast) Tablets)
-
Astra
Zeneca (Prilosec (omeprazole) Delayed-Release Capsules)
-
AstraZeneca
(Plendil (felodipine) extended-release tablets)
Aventis Pharmaceuticals
- Aventis
Pharmaceuticals (Allegra® (fexofenadine HCl) Tablets)
- Aventis
Pharmaceuticals (Taxotere (docetaxel) for Injection Concentrate)
- Aventis Pharmaceuticals (Taxotere
(docetaxel) for Injection)
- Aventis Pharmaceuticals (Lovenox
(enoxaparin sodium) Injection)
- Aventis Pharmaceuticals
(Nilandron® (nilutamide) Tablets)
- Aventis Pharmaceuticals
(Amaryl® (glimepiride) Tablets)
- Aventis Pharmaceuticals (Allegra
(fexofenadine hydrochloride) Capsules 60 mg)
Avlon Industries
- Avlon
Industries (BMIS Inspection)
Axium Healthcare Pharmacy
- Axium
Healthcare Pharmacy (Domperidone)
Barr Research, Inc.
- Barr
Research, Inc. (Seasonale® (levonorgestrel/ethinyl estradiol) Tablets)
Bausch & Lomb
Pharmaceuticals Inc.
- Bausch & Lomb (Alrex
(loteprednol etabonate ophthalmic suspension, 0.2%))
Baxter Pharmaceutical
Products, Inc.
- Baxter Pharmaceutical Products, Inc.
(Brevibloc (esmolol hydrochloride) Injection)
Bayer Corporation/Bayer HealthCare Pharmaeceuticals, Inc.
-
Bayer
HealthCare Pharmaceuticals, Inc. (Mirena® (levonorgestrel-releasing
intrauterine system))
-
Bayer
Healthcare Pharmaceuticals, Inc. (LEVITRA; YAZ; Mirena)
-
Bayer
HealthCare L.L.C. (Bayer Aspirin with Hearth Advantage)
-
Bayer
HealthCare L.L.C. (Bayer Women's Low Dose Aspirin + Calcium)
-
Bayer HealthCare Pharmaceuticals, Inc. (YAZ® (drospirenone
and ethinyl estradiol) Tablets)
-
Bayer
Pharmaceuticals Corporation (Levitra° (vardenafil HCl) Tablets)
-
Bayer Corporation (Avelox (moxifloxacin
HCL))
-
Bayer
Corporation (Vardenafil)
-
Bayer
Corporation (Avelox (moxifloxacin hydrochloride) Tablets
Berlex Laboratories
- Berlex
Laboratoris (Yasmin (drospirenone/ethinyl estradiol) Tablets)
- Berlex Laboratories (Quadramet (Samarium Sm-153
lexidronam) Injection)
- Berlex Laboratories
(Magnevist (gadopentetate dimeglumine) Injection)
- Berlex Laboratories (Fludara®
(fludarabine phosphate) for injection)
Better-Bodies
- Better-Bodies
(Adipokinetix)
Bigmar-Bioren SA
-
Bigmar-Bioren SA (Site Inspection)
Bio-Health
-
Bio-Health (Z-LABS Progesterone Cream)
Biogen Idec, Inc.
- Biogen
Idec, Inc. (Zevalin® (ibritumomab tiuxetan))
BioMarin Pharmaceutical, Inc.
- BioMarin
Pharmaceutical, Inc. (Orapred® (prednisolone sodium phosphate oral
solution))
Bioniche Pharma Group Limited
-
Bioniche Pharma USA LLC (Sotradecol™ (sodium tetradecyl sulfate
injection))
-
Bioniche Pharma Group Limited (Sotradecol (sodium tetradecyl sulfate
injection))
Biovail Pharmaceuticals
- Biovail
Pharmaceuticals (Cedax® (ceftibuten))
Bird's Hill Pharmacy
- Bird's Hill Pharmacy (Nicotine Lollipops)
B.F. Ascher & Company, Inc.
- B.F. Ascher & Company, Inc.
(Melagesic PM Caplets)
Block Drug Company, Inc.
- Block Drug Company, Inc. (Atridox
(doxycycline hyclate, 10%))
Boehringer
Ingelheim/Roxane, Inc.
-
Boehringer Ingelheim Pharmaceuticals, Inc. (Spiriva HandiHaler; Flomax
Capsules; Mirapex Tablets)
-
Boehringer
Ingelheim Roxane, Inc. (Roxanol Oral Solution, 20 mg/ml; Roxicodone
Tablets, 5 mg)
-
Boehringer-Ingelheim (Mirapex® (pramipexole dihydrochloride))
-
Boehringer
Ingelheim Pharmaceuticals, Inc. (Spiriva® Handihaler® (tiotropium
bromide inhalation powder))
-
Boehringer
Ingelheim Pharmaceuticals, Inc. (Aggrenox® (aspirin/extended-release
dipyridamole) Capsules)
-
Boehringer Ingelheim Pharmaceuticals, Inc. (Viramune (nevirapine)
Tablets and Viramune (nevirapine) Oral Suspension)
-
Boehringer Ingelheim Pharmaceuticals, Inc. (Atrovent (ipratropium
bromide) Inhalation Aerosol and Combivent (ipratropium bromide and
albuterol sulfate) Inhalation Aerosol)
- Boehringer Ingelheim
Pharmaceuticals, Inc. (Viramune (nevirapine) Tablets and Oral
Suspension)
Bracco Diagnostics, Inc.
- Bracco Diagnostics,
Inc.(MultiHance (gadobenate dimeglumine, Gd-BOPTA))
Bradley Pharmaceuticals
- Bradley
Pharmaceuticals (Pamine (methscopolamine bromide))
Braintree Laboratories Inc.
-
Braintree Laboratories Inc.
(Phoslo (calcium acetate) tablets)
Bristol-Myers Squibb
-
Bristol-Myers
Squibb (Pravachol (pravastatin sodium) Tablets)
-
Bristol-Myers Squibb
(UFT (uracil and tegafur) capsules)
-
Bristol-Myers Squibb
(Ifex® (ifosfamide) Injection)
-
Bristol-Myers
Squibb (Vaniqa (eflornithine hydrochloride) Cream, 13.9%)
-
Bristol-Myers Squibb (Tequin
(gatifloxacin) Tablets/Injection)
-
Bristol-Myers Squibb ( Hydrea and Droxia capsules)
CanaRx Services, Inc.
- CanaRx
Services, Inc. (Prescription Drug Shipments)
Cape Drugs
- Cape
Drugs (Domperidone)
Capstone Clinical Trials, Inc.
-
Capstone Clinical Trials, Inc. (Clinical Investigation)
Carter Wallace
-
Carter
Wallace (Astelin (azelastine HC1) Nasal Spray)
Celgene Corporation
- Celgene Corporation (Thalomid
(thalidomide) Capsules)
Central
Pennsylvania Clinical Research
- Central
Pennsylvania Clinical Research (Celebrex (celecoxib) capsules)
Centocor, Inc.
- Centocor,
Inc. (Remicade® (infliximab))
Cephalon, Inc.
- Cephalon,
Inc. (Treanda® (bendamustine hydrochloride) for Injection)
- Cephalon,
Inc. (Provigil® (modafinil) Tablets [C-IV])
- Cephalon Inc. (Provigil
(modafinil) Tablets)
Changzhou SPL Company, Ltd
-
Changzhou SPL Company, Ltd (Site Inspection)
CHRISTUS Schumpert Health System
- CHRISTUS
Schumpert Health System (Bioresearch Monitoring Program/IRB)
CIBA Vision
- CIBA Vision (Rescula (unoprostone
isopropyl ophthalmic solution), 0.15%)
Clinical Site (Alkis Togias, M.D.)
-
Clinical Site (Alkis Togias, M.D.)
Clonmel Healthcare Ltd.
-
Clonmel Healthcare Ltd. (Inspection Report)
Coast Institutional Review Board
-
Coast IRB,
LLC (Clinical Investigation)
-
Coast Institutional Review Board (Site Inspection)
Colleganex
Pharmaceuticals, Inc.
- Colleganex Pharmaceuticals
(Periostat (doxycycline hyclate), 20 mg Capsules)
The Compounding Pharmacy
- The Compounding Pharmacy (Nicotine Lollipops and Nicotine Lip Balm)
Comprehensive Clinical Research
- Comprehensive Clinical Research (Clinical Study Inspection)
Connetics Corporation
- Connetics Corp. (LuxigTM
(betamethasone valerate) Foam, 0.12%)
- Connetics Corp. (LuxigTM
(betamethasone valerate) Foam, 0.12%)
Corixa Corporation
- Corixa
Corporation (BEXXAR® (Tositumomab and Iodine I 131 Tositumomab))
Cornerstone Therapeutics, Inc.
-
Cornerstone Therapeutics, Inc. (Spectracef® (cefditoren pivoxil)
Tablets)
Coulston Foundation
- Coulston Foundation (Site Inspection)
Craig M. Buettner, M.D.
-
Craig M. Buettner, M.D. (Clinical Investigation)
Critical Therapeutics, Inc.
-
Critical Therapeutics, Inc. (Zyflo® Filmtab® (zileuton tablets))
Cubist Pharmaceuticals, Inc.
- Cubist
Pharmaceuticals (CubicinTM (daptomycin for injection))
- Cubist Pharmaceuticals (Daptomycin)
Cytogen Corporation
- Cytogen
Corporation (Quadramet (Samarium SM 153 Lexidronam) Injection)
Daiichi Sankyo, Inc.
-
Daiichi Sankyo, Inc. (Evoxac Capsules (cevimeline hydrochloride))
DAVA Pharmaceuticals, Inc.
- DAVA
Pharmaceuticals, Inc. (VoSpire ER® (albuterol sulfate) Extended-Release
Tablets)
Delta Synthetic Co., Ltd
-
Delta Synthetic Co., Ltd (API Site Inspection)
Dexcel Pharma Technologies Ltd.
- Dexcel
Pharma Technologies Ltd. (PerioChip® (chlorhexidine gluconate) 2.5 mg)
Dey Laboratories
- Dey Laboratories (Ipratropium Bromide inhalation
Solution 0.02%)
Diabetes Tea
-
Diabetes Tea (Overdrive)
Discount Prescriptions from Canada,
Inc.
-
Discount Prescriptions from Canada, Inc. (Prescription Drugs
Importation)
Discovery Alliance,
Inc.
-
Discovery Alliance, Inc. (Clinical Study)
Discovery
Experimental & Development Inc
-
Discovery
Experimental & Development Inc (Liquid Deprenyl Citrate)
Doak Dermatologics
- Doak
Dermatologics (Solaraze (diclofenac sodium) Gel, 3 %)
DuPont
Pharmaceuticals Company
-
DuPont Pharmaceuticals
Company (Sustiva (efavirenz) capsules)
-
DuPont
Pharmaceuticals Company (Innohep (tinzaparin sodium injection))
Duramed Pharmaceuticals, Inc.
- Duramed
Pharmaceuticals, Inc. (Cenestin ® (synthetic conjugated estrogens, A)
Tablets)
DUSA Pharmaceuticals, Inc.
- DUSA
Pharmaceuticals, Inc. (Levulan Kerastick (aminolevulinic acid HCl) for
Topical Solution, 20%)
Dutch Ophthalmic USA
- Dutch
Ophthalmic USA (VisionBlue® (trypan blue ophthalmic solution))
Eisai, Inc.
- Eisai, Inc.
(Dacogen® (decitabine))
Elan
Pharmaceuticals
-
Elan
Pharmaceuticals (Zanaflex (tizanidine HCl) Tablets)
-
Elan Pharmaceuticals
(Zanaflex (tizanidine HCl) Tablets)
-
Elan
Pharmaceuticals (Corlopam (fenoldopam mesylate) Injection)
Eli Lilly and
Company
-
Eli Lilly
and Company (Cymbalta (duloxetine hydrochloride) Delayed-Release
Capsules for Oral Use)
-
Eli Lilly
and Company (Cymbalta Capsules; EVISTA Tablet, and Gemzar for
Injection)
-
Eli Lilly
and Company (CYMBALTA© (duloxetine hydrochloride) Delayed-release
Capsules)
-
Eli Lilly
and Company (Alimta® pemetrexed for injection)
-
Eli Lilly
and Company (Strattera (atomoxetine HCl))
-
Eli Lilly and
Company (Sarafem (fluoxetine HCI) Tablets)
-
Eli Lilly
and Company (Evista (raloxifene HCl) Tablets)
-
Eli Lilly and
Company (IND Promotion)
-
Eli Lilly and Company
(Tapazole (methimazole))
Endo
Pharmaceuticals Inc.
-
Endo
Pharmaceuticals (Lidoderm® (Lidocaine Patch 5%))
-
Endo Pharmaceuticals
(Zydone (hydrocodone bitartrate and acetaminophen tablets)
Enzon Pharmaceuticals, Inc.
- Enzon
Pharmaceuticals, Inc. (Abelcet® (Amphotericin B Lipid Complex
Injection))
Evangeline G. Gonzalez, M.D.
- BMIS
Inspection (Warning Letter)
Expedite-Rx
-
Expedite-Rx (Prescription Drug Importation)
Family Health Care of Hendersonville
-
Family Health Care of Hendersonville (Clinical Investigation)
FIDIA s.p.a.
-
FIDIA s.p.a.
(Site Inspection)
Forest Laboratories,
Inc
-
Forest
Laboratories, Inc. (Bystolic® (nebivolol) Tablets)
-
Forest
Laboratories, Inc. (Celexa (citalopram HBr))
-
Forest
Laboratories, Inc. (Levothroid (levothyroxine sodium tablets, USP))
Fujisawa
Healthcare, Inc.
-
Fujisawa
Healthcare, Inc. (Prograf® (tacrolimus))
-
Fujisawa
Healthcare, Inc. (Protopic (tacrolimus) Ointment 0.03%, 0.1%)
-
Fujisawa
Healthcare, Inc. (Protopic (tacrolimus 0.03% and 0.1%) Ointment)
G.D. Searle & Co.
-
G.D. Searle
& Co. (Celebrex (celecoxib) capsules)
-
G.D. Searle &
Co. (Celebrex (celecoxib) capsules and Anibien (zolpidem tartrate)
tablets)
Galderma
Laboratories, L.P.
-
Galderma
Laboratories (Tri-Luma® Cream)
-
Galderma
Laboratories (Differin (adapalene gel) Gel, 0.1%)
GelTex
Pharmaceuticals
-
GelTex
Pharmaceuticals (Renagel Capsules/Tablets)
Gemeindezentrum
-
Gemeindezentrum
(Site Inspection)
Gene Logic, Inc.
- Gene
Logic, Inc. (BMIS Inspection)
Genetech
-
Genentech, Inc. (Avastin; LUCENTISTM; RITUXAN®; Xolair®; HERCEPTIN®;
Pulmozyme®)
-
Genentech (Nutropin)
-
Genetech (Nutropin
Depot [somatropin (rDNA origin) for injectable suspension])
Genpharm, Inc.
-
King & Spaulding (For Genpharm) (Amnesteem (isotretinoin) Capsules)
Genzyme Corporation
-
Genzyme
Corporation (Cerezyme (imiglucerase for injection))
Gilead Sciences
-
Gilead
Sciences (LetairisTM (ambrisentan) Tablets)
-
Gilead
Sciences (Viread® (tenofovir disoproxil fumarate) Tablets)
-
Gilead Sciences
(Viread® (tenofovir disoproxil fumarate) Tablets)
GlaxoSmithKline/Glaxo Wellcome
-
GlaxoSmithKline,
Inc. (AVODART® (dutasteride) Soft Gelatin Capsules)
-
GlaxoSmithKline, Inc. (TYKERB (lapatinib) Tablets)
-
GlaxoSmithKline, Inc. (Flonase® (fluticasone propionate) Nasal Spray,
50 mcg
-
GlaxoSmithKline, Inc. (Zovirax® (acyclovir) Ointment 5%)
-
GlaxoSmithKline, Inc. (Coreg (carvedilol) Tablets)
-
GlaxoSmithKline, Inc. (Paxil® CR (paroxetine HCl) Controlled Release
Tablets)
-
GlaxoSmithKline, Inc. (Flonase (fluticasone propionate) Nasal Spray,
50 mcg)
-
GlaxoSmithKline,
Inc. (Imitrex (sumatriptan succinate) Tablets)
-
GlaxoSmithKline
Inc. (Avandia® (rosiglitazone maleate) Tablets)
-
GlaxoSmithKline
Inc. (Avandia® (rosiglitazone maleate) Tablets)
-
GlaxoSmithKline
Inc. (Navelbine® (vinorelbine tartrate) Injection)
-
Glaxo
Wellcome, S.p.A. (Site Inspection)
-
Glaxo Wellcome (Flovent
(fluticasone propionate) Inhalation Aerosol)
-
Glaxo
Wellcome (LOTRONEX (alosetron hydrochloride) Tablets)
-
Glaxo Wellcome (Relenza
(zanamivir for inhalation))
-
Glaxo Wellcome (Flonase
(fluticasone propionate) Nasal Spray (Newspaper))
-
Glaxo Wellcome (Flonase
(fluticasone propionate) Nasal Spray (TV))
Granules India
Limited
-
Granules India Limited (Site Inspection)
Guilford Pharmaceuticals, Inc.
- Guilford
Pharmaceuticals, Inc. (Gliadel Wafer (polifeprosan 20 with carmustine
implant))
Hemispherx
Biopharma, Inc.
-
Hemispherx
Biopharma, Inc. (Ampligen)
Herbtech
-
Herbtech
(Ephedra or Ma Huang)
Herron, Jerry M. M.D.
- Jerry
M. Herron, M.D. (BMIS Inspection)
Heyltex Corporation
-
Heyltex
Corporation (IND Inspection)
Hoffmann-La Roche
-
Hoffman-LaRoche, Inc. (BONIVA Tablets; PEGASYS Injection; XELODA
Tablets)
-
Hoffman-La
Roche Inc. (FuzeonTM (enfuvirtide) for Injection)
-
Hoffmann-La
Roche Inc. (Xeloda® (capecitabine) Tablets)
-
Hoffmann-LaRoche,
Inc. (Accutane (isotretinoin) Capsules)
-
Hoffman-La Roche,
Inc. (Tamiflu (oseltamivir phosphate) Capsules)
-
Hoffmann-La Roche, Inc.
(Xeloda® (capecitabine) Tablets)
-
Hoffman-La Roche, Inc.
(TAMIFLU (oseltamivir phosphate))
-
Hoffman La Roche
Inc. (Xenical (orlistat) Capsules)
-
Hoffmann-La Roche
(Xenical (orlistat tetrahydrolipstatin))
Hospital Municipal de San Juan
-
Hospital Municipal de San Juan (Clinical Investigation)
Human Investigation Committee
of Houston, Texas
- Human
Investigation Committee of Houston, Texas (IRB Inspection)
ICN Pharmaceuticals, Inc.
- ICN Pharmaceuticals (Efudex®
(fluorouracil) topical solutions and cream)
ICON Clinical Research
- ICON Clinical
Research (Contract monitoring organization (CRO))
Indevus Pharmaceuticals, Inc.
-
Indevus Pharmaceuticals, Inc. (Sanctura® (trospium chloride) 20 mg
Tablets)
Institute for
Advanced Clinical Research
- Institute for Advanced
Clinical Research (Clinical Study)
InterMune, Inc.
-
InterMune, Inc. (INFERGEN® (Interferon alfacon-1))
Iroko Pharmaceuticals, LLC
- Iroko
Pharmaceuticals, LLC (Indocin (indomethacin) Oral Suspension)
ISTA Pharmaceuticals, Inc.
-
ISTA Pharmaceuticals, Inc. (Vitrase (hyaluronidase injection))
ITT Research Institute
- ITT
Research Institute (Inspection)
Janssen Pharmaceuticals
Inc./Research Foundation
- Janssen
Pharmaceutica, Inc. (Duragesic® (fentanyl transdermal system) CH)
- Janssen
Pharmaceutica, Inc. (Risperdal® (risperidone))
-
Janssen Research Foundation (Reminyl (galantamine HBr))
- Janssen Research
Foundation (Sporanox (Itraconazole) Capsules)
- Janssen Pharmaceuticals Inc. (Sporanox
(itraconazole) Capsules)
Jerome
Stevens Pharmaceuticals, Inc.
-
Jerome
Stevens Pharmaceuticals Inc. (THYROX (Levothyroxine Sodium Tablets,
USP))
Jiangsu
Hengrui Medicine Co., LTD.
-
Jiangsu
Hengrui Medicine Co., LTD. (Site Inspection)
-
Jiangsu Hengrui Medicine Co., LTD. (Site Inspection)
JIIM, L.L.C.
-
JIIM,
L.L.C. (Doctor's Lotion)
Johnson & Johnson
-
Johnson &
Johnson, Consumer & Personal Products Worldwide (ERTACZO™
(sertaconazole nitrate) Cream, 2%)
-
Johnson & Johnson
Pharmaceutical Research & Development, LLC (Bioresearch Monitoring
Program/IRB)
-
Johnson &
Johnson (ULTRAM® ER (tramadol HCl) Extended-Release Tablets)
-
Johnson &
Johnson Pharmaceutical Services, L.L.C. (PREZISTA™ (darunavir) Tablet)
-
Johnson &
Johnson (CONCERTA® (methylphenidate HCl) Extended-release Tablets
[CII] )
-
Johnson &
Johnson Consumer Companies, Inc. (Retin-A Micro (tretinoin gel)
microsphere, 0.1%)
-
Johnson
& Johnson Consumer Companies, Inc. (Renova (tretinoin emollient
cream) 0.05%)
Jones Pharma
Inc.
- Jones Pharma Incorporated (Levoxyl,
levothyroxine sodium tablets, USP)
Kalchem International, Inc.
- Kalchem
International, Inc. (Pharmacy Compounding of Domperidone)
King
Pharmaceuticals, Inc.
-
King
Pharmaceuticals, Inc. (EMBEDA™ (morphine sulfate and naltrexone
hydrochloride) Extended Release Capsules)
-
King
Pharmaceuticals, Inc. (Avinza® (morphine sulfate extended-release
capsules) CII)
-
King
Pharmaceuticals (Altace (ramipril) Capsules)
Knoll
Pharmaceutical
-
Knoll Pharmaceutical
(Synthroid (levothyroxine sodium) Tablets)
Kos
Pharmaceuticals
-
Kos Pharmaceuticals
(Niaspan (niacin extended-release) Tablets)
Kunshan Chemical & Pharmaceutical Company
- Kunshan
Chemical & Pharmaceutical Company (Site Inspection)
KV Pharmaceutical Company
- KV
Pharmaceutical Company (ClindesseTM (clindamycin phosphate)
Vaginal Cream, 2%)
Laboratoire Atlas, Inc.
-
Laboratoire Atlas, Inc. (Human Drug Finished Product)
Lehigh Valley Technologies, Inc.
-
Lehigh Valley Technologies, Inc. (Codeine Sulfate Tablets, 30 mg & 60
mg)
Lifecycle
Ventures
-
Lifecycle
Ventures (Ceftin Tablets(cefuroxime axetil tablets))
Ligand
Pharmaceuticals, Inc.
-
Ligand
Pharmaceuticals, Inc. (ONTAK (denileukin diftitox) and Targretin
(bexarotene) capsules)
-
Ligand
Pharmaceuticals Inc. (Targretin® (bexarotene) capsules)
Lilly ICOS LLC
-
Lilly ICOS LLC (IC351)
Linden Research Consultant
-
Linden Research Consultant (BMIS Inspection)
Litron Laboratories, Ltd.
-
Litron Laboratories, Ltd. (Inspection)
Long
March Pharmaceuticals
-
Long
March Pharmaceuticals (Site Inspection)
Mallinckrodt, Inc.
-
Mallinckrodt, Inc. (Tramadol Hydrochloride Tablets, 50 mg)
Mark F. Gordon, M.D.
- Mark
F. Gordon, M.D. (Clinical Investigation)
Massachusetts General
Hospital
-
Massachusetts General Hospital (Clinical Investigation)
Maxim
Pharmaceuticals, Inc.
-
Maxim
Pharmaceuticals, Inc. (CepleneTM (histamine dihydrochloride) for
Injection)
-
Maxim
Pharmaceuticals, Inc. (Histamine Dihydrochloride Injection)
Mayne Pharma Pty., Ltd.
- Mayne
Pharma (USA), Inc. (M.V.I.-12 (Multi-Vitamin Infusion without vitamin K))
-
Mayne Pharma Pty., Ltd. (Site Inspection)
MD Anderson Cancer Center
-
MD Anderson Cancer Center (Inspection)
MDS Pharma Services/MDS Inc.
- MDS Inc. (BIMO Inspection)
- MDS Pharma
Services (BMIS Inspection)
- MDS Pharma
Services (Facility Inspection)
Medicis
Pharmaceutical Corp.
-
Medicis
Pharmaceutical Corp. (Loprox Shampoo (ciclopirox))
-
Medicis
Pharmaceutical Corp. (Loprox (ciclopirox) 0.77% Cream and Lotion)
MedImmune
- MedImmune
Oncology Inc. (Ethyol® (amifostine) for Injection)
Merck & Co.
Inc.
-
Merck & Co,
Inc. (Januviatm; Propecia; Singular; Emend)
-
Merck &
Co. Inc. (Vioxx (rofecoxib) tablets)
-
Merck &
Co. Inc. (Cancidas (caspofungin acetate))
-
Merck &
Co. Inc. (Fosamax (alendronate sodium tablets))
-
Merck & Co. Inc.
(Crixivan (indinavir sulfate) tablets)
-
Merck & Co. Inc.
(Fosamax (alendronate sodium) and Vioxx (rofecoxib)
MGI Pharma, Inc.
- MGI
Pharma, Inc. (Gliadel® Wafer (polifeprosan 20 with carmustine
implant))
MGS Representations
- MGS
Representations (All Soapopular hand sanitizers)
Miami Institute for Medical Research
-
Miami Institute for Medical Research (Clinical Investigation)
Moscow City Hospital
-
Moscow City Hospital, Professor Olga D. Ostroumova (Clinical
Inspection)
Murray, Robert Michael MD
-
Robert Michael Murray, MD (BMIS Inspection)
Muscle Lane,
Inc.
-
Muscle Lane, Inc. (Adrenalin)
Nabi
-
Nabi
(Aloprim (allopurinol sodium) for
Injection)
Nephrx
- Nephrx
(Calcitriol Injection 1 mcg/mL)
Neurological Associates of Albany
-
Neurological Associates of Albany (Clinical Investigation)
Niagara Pharmaceuticals Inc.
- Niagara
Pharmaceuticals Inc. (Site Inspection)
Noli R Zosa, M.D.
- Noli R
Zosa, M.D. (Clinical Investigation)
North American Science
Associates, Inc.
- North
American Science Associates, Inc. (BMIS Inspection)
Northeast General
Pharmaceutical Factory
-
Northeast General Pharmaceutical Factory (Site Inspection)
Novartis Ophthalmics
-
Novartis Ophthalmics (Zaditor (ketotifen fumarate ophthalmic solution),
0.025%)
Novartis
Pharmaceuticals Corporation
-
Novartis
Pharmaceutical (Femara, Diovan, Exforge, Exjade, and Gleevec)
-
Novartis
Pharmaceuticals (Focalin XR® (dexmethylphenidate hydrochloride)
extended-release capsules CII)
-
Novartis
Pharmaceuticals (Trileptale (oxcarbazepine) Tablets and Oral
Suspension)
-
Novartis
Pharmaceuticals (Exelon® (rivastigmine tartrate) Capsules and Oral
Solution)
-
Novartis
Pharmaceuticals (Diovan® (valsartan) Tablets)
-
Novartis
Pharmaceuticals (Lamisil® (terbinafine hydrochloride) 250 mg Tablets)
-
Novartis Pharmaceuticals (Transderm Scop (scopolamine) Transdermal
Therapeutic System)
-
Novartis
Pharmaceuticals (Comtan® (entacapone) Tablets)
-
Novartis
Pharmaceuticals (Transderm Scop (scopolamine) Transdermal Therapeutic System)
-
Novartis
Pharmaceuticals (Miacalcin Nasal Spray and Exelon Capsules)
-
Novartis
Pharmaceuticals Corporation (Femara (letrozole) Tablets
-
Novartis
Pharmaceuticals Corporation (Neoral Soft Gelatin Capsules, Neoral Oral
Solution)
-
Novartis
Pharmaceuticals Corporation (Diovan (valsartan) Capsules)
-
Novartis
Pharmaceuticals Corporation (Lescol (fluvastatin sodium) Capsules)
Novo Nordisk
Pharmaceuticals
-
Novo
Nordisk Pharmaceuticals (Prandin (repaglinide) Tablets)
Nozin LLC
- Nozin LLC
(Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu
Virus)
Omicron Quimica, S.A.
- Omicron Quimica, S.A. (Site Inspection)
Omni Nutraceuticals
-
Omni Nutraceuticals
(Inholtra Joint Pain Caplets and Inholtra Joint Pain Plus Caplets)
onlinepharmacyy.com
-
onlinepharmacyy.com (Internet Marketing of Unapproved and Misbranded
Drugs)
Optima Worldwide,
Ltd
-
Optima
Worldwide, Ltd (GEDA PLUSTM and SURETETM)
Organon, Inc.
- Organon,
Inc. (Follistim® (follitropin beta for injection) )
Ortho-McNeil Pharmaceutical, Inc.
-
Ortho-McNeil Pharmaceutical, Inc. (Topamax (topiramate) Tablets and
Topamax (topiramate capsules) Sprinkles)
Ozelle Pharmaceuticals
-
Ozelle
Pharmaceuticals (Anvirzel TM)
Palatin Technologies, Inc.
-
Palatin Technologies, Inc. (NeutroSpecTM [Kit for the Preparation of
Technetium (99m Tc) fanolesomab])
Palm Beach Gardens Medical Center
-
Palm Beach Gardens Medical Center (Clinical Investigation)
Pedinol Pharmacal, Inc.
-
Pedinol Pharmacal, Inc. (Nalfon® (fenoprofen calcium capsules) 200 mg
and 400 mg)
Pfizer Inc.
- Pfizer,
Inc. (AROMASIN; CADUET; CHANTIX; Detrol LA; LYRICA; CELEBREX)
- Pfizer,
Inc. (Viagra® (sildenafil citrate) Tablets)
- Pfizer,
Inc. (Zoloft® (sertraline HCl) Tablets)
- Pfizer,
Inc. (Zyrtec® (cetirizine HCl) Tablets, Syrup, and Chewable Tablets)
- Pfizer,
Inc. (Celebrex & Bextra)
- Pfizer,
Inc. (Viagra® (sildenafil citrate) Tablets)
- Pfizer,
Inc. (Zyrtec-D 12 Hour® (cetirizine HC15 mg/pseudoephedrine HCl 120 mg)
Extended Release Tablets)
- Pfizer,
Inc. (Camptosar® (irinotecan hydrochloride injection))
- Pfizer Inc.
(Covera-HS® (verapamil hydrochloride))
-
Pfizer Inc. (Geodon (ziprasidone HCI))
- Pfizer
Inc. (Lipitor (atorvastatin calcium) Tablets)
- Pfizer,
Inc. (Neurontin® (gabapentin))
- Pfizer, Inc. (Zyrtec (cetirizine
HCl) Tablets)
-
Pfizer
Pharmaceuticals (Lipitor (atorvastatin calcium) Tablets)
-
Pfizer
Pharmaceuticals (Neurontin (gabapentin))
-
Pfizer
Pharmaceuticals (Estrostep (norethindrone acetate and ethinyl
estradiol) Tablets)
-
Pfizer
Pharmaceuticals (Zithromax (azithromycin for oral suspension))
-
Pfizer
Pharmaceuticals (Viagra (sildenafil citrate) tablets)
PharmaKinetics
Laboratories Inc.
-
PharmaKinetics
Laboratories Inc. (Site Inspection)
PharmaMar,
USA, Inc.
-
PharmaMar, USA, Inc. (Ecteinasicidin-743)
Pharmcia
Corporation
-
Pharmacia
Corporation (Xalatan (latanoprost ophthalmic solution))
-
Pharmacia Corporation
(Genotropin (somatropin [rDNA] origin for injection))
-
Pharmacia
Corporation (Celebrex (celecoxib) capsules)
-
Pharmacia
Corporation (Site Inspection, Stockholm, Sweden)
-
Pharmacia
Corporation (Site Inspection, Strangnas, Sweden)
-
Pharmacia &
Upjohn (Detrol (tolterodine tartrate tablets))
-
Pharmacia &
Upjohn, S.p.A. (Site Inspection)
-
Pharmcia
& Upjohn (Camptosar Injection (irinotecan HCI injection))
Pliva Croatia Ltd.
- Pliva
Croatia Ltd. (Site Inspection)
Praecis
Pharmaceuticals Incorporated
- Praecis Pharmaceuticals
(PlenaxisTM (abarelix for injectable suspension))
Presutti Laboratories, Inc.
- Presutti
Laboratories, Inc. (TindamaxTM (tinidazole tablets))
PrimaPharm, Inc.
-
PrimaPharm, Inc. (HydaseTM (hyaluronidase Injection, USP) 150 Units/mL)
Procter &
Gamble Pharmaceuticals, Inc.
-
Procter and Gamble (VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus
Vitamin C)
- Procter & Gamble (Actonel
(risedronate sodium tablets))
Psypharma Clinical Research, Inc.
-
Psypharma Clinical Research, Inc. (Bioresearch Monitoring Program/IRB)
Protherics, Inc.
-
Protherics, Inc. (VoraxazeTM (glucarpidase))
Purdue Pharma L.P.
-
Purdue Pharma L.P. (OxyContin© (oxycodone HCl controlled-release)
Tablets)
- Purdue Pharma L.P. (OxyContin
(oxycodone hydrochloride Controlled-Release) tablets)
Q-Based Solutions, Inc.
- Q-Based
Solutions, Inc. (Products Related to the H1N1 Flu Virus)
Quinones, Manuel J. M.D.
-
Manuel J. Quinones, M.D. (Clinical Investigation)
Radiant Research
-
Radiant Research (Clinical Study)
Ranbaxy Laboratories Limited
-
Ranbaxy Laboratories Limited (Dewas, India Site Inspection)
-
Ranbaxy Laboratories Limited (Batamandi, India Site Inspection)
- Ranbaxy
Laboratories Limited (Site Inspection)
Raymond E. Tidman, M.D.
-
Raymond E. Tidman, M.D. (Clinical Investigation Inspection)
Reliant Pharmaceuticals, Inc.
-
Reliant Pharmaceuticals, Inc. (Rythmol© SR (propafenone HCl) extended
release Capsules)
Replidyne, Inc.
-
Replidyne, Inc. (BMIS Inspection)
Research Consortium, Inc.
- Research
Consortium, Inc. (Bioreaserch Monitoring)
Roche Laboratories, Inc.
- Roche Laboratories (Tasmar (tolcapone) Tablets)
Rochester General Hospital
- Rochester General Hospital
(Clinical Study)
Romark Laboratories, L.C.
- Romark
Laboratories, L.C. (Alinia® (nitazoxanide) Tablets and (nitazoxanide)
for Oral Suspension)
Sandoz, Inc.
- Sandoz,
Inc. (Ergotamine Tartrate)
- Sandoz,
Inc. (Bupropion hydrochloride extended-release tablets (SR))
Sankyo Pharma, Inc.
- Sankyo
Pharma, Inc. (Benicar (olmesartan))
Sanofi-Aventis
-
Sanofi-Aventis U.S. LLC (UROXATRAL® (alfuzosin HCl) Extended-Release
Tablets for Oral use)
-
Sanofi-Aventis (Taxotere® (docetaxel) Injection Concentrate, Intravenous
Infusion (IV))
-
Sanofi-Aventis (BMIS Inspection)
Sanofi Pasteur, Inc.
-
Sanofi Pasteur, Inc. (Site Inspection)
Sanofi-Synthelabo, Inc.
- Sanofi-Synthelabo Inc. (Plavix
(clopidogrel bisulfate) 75 mg Tablets)
- Sanofi-Synthelabo, Inc. (Plavix
(clopidogrel bisulfate) Tablets)
- Sanofi-Synthelabo, Inc. (Eloxatin
(oxaliplatin))
Santen, Inc.
- Santen Inc.
(Quixin (levofloxacin ophthalmic solution), 0.5%)
Schering Corporation
- Schering
Corporation (Nasonex® (mometasone furoate monohydrate) Nasal Spray, 50
mcg)
- Schering
Corporation (Foradil Aerolizer® (formoterol fumarate inhalation powder)
12mcg)
- Schering Corporation (Temodar®
(temozolomide) Capsules)
- Schering Corporation
(Nasonex® (mometasone furoate monohydrate) Nasal Spray)
- Schering Corporaton (Claritin
(loratadine)
Tablets)
- Schering Corporaton (Claritin (loratadine)
Tablets)
- Schering Corporation (Claritin (loratadine)
Tablets)
Scientifically Advanced Nutrition
- Scientifically Advanced Nutrition (Hollywood Cuts)
Scios, Inc.
- Scios, Inc.
(Natrecor© (nesiritide) for Injection)
Sepracor, Inc.
- Sepracor (Xopenex (levalbuterol
HC1) Inhalation Solution)
Shanghai Medical Ltd.
-
Shanghai Medical Ltd. (Facility Inspection)
Shanghai Shen Xin
Pharmaceutical Factory
-
Shanghai
Shen Xing Pharmaceutical Factory (Site Inspection)
Shionogi USA, Inc.
-
Shionogi USA, Inc. (Cedax® (ceftibuten capsules and ceftibuten for
oral suspension))
Shire
Laboratories, Inc./Shire Development, Inc.
-
Shire
Development, Inc. (Fosrenol® (lanthanum carbonate hydrate) Chewable
Tablets)
-
Shire Development, Inc. (Adderall XR® Capsules)
-
Shire
Development, Inc. (Fosrenol® (lanthanum carbonate))
-
Shire
Pharmaceutical Development, Inc. (ProAmatine (midodrine hydrochloride) Tablets)
-
Shire
Laboratories, Inc. (Fareston (toremifene citrate))
Sigma-Tau
Pharmaceuticals Inc.
-
Sigma-Tau
Pharmaceuticals Inc. (Carnitor, levocarnitine)
Similasan AG
-
Similasan AG (Site Inspection)
Sitek Research Laboratories
- Sitek
Research Laboratories (BMIS Inspection)
SkyePharma
-
SkyePharma ( DepoCyto®
(cytarabine liposome injection))
SmithKline
Beecham Pharmaceuticals
-
SmithKline
Beecham Pharmaceuticals (Argatroban Injection (100mg/mL))
-
SmithKline
Beecham Pharmaceuticals (Avandia® (rosiglitazone nialeate) Tablets)
-
SmithKline
Beecham Pharmaceuticals (Famvir (famciclovir))
-
SmithKline
Beecham Pharmaceuticals (Bactoban Nasal (calcium mupirocin))
Societa
Italiana Medicinali Scandicci
-
Societa
Italiana Medicinali Scandicci (Site Inspection)
SOL
Pharmaceuticals Limited
-
SOL
Pharmaceuticals Limited (Site Inspection)
St.
Anthony Memorial Health Center
-
St. Anthony
Memorial Health Center (Site Inspection)
Supergen, Inc.
-
SuperGen,
Inc. (Nipent® (pentostatin) for Injection)
-
SuperGen, Inc.
(Rubitecan)
-
SuperGen,
Inc. (Nipent® (pentostatin) for Injection)
Synsorb Biotech, Inc.
-
Synsorb
Biotech Inc. (SYNSORB PK)
Takeda Pharmaceuticals North America,
Inc.
- Takeda
Pharmaceuticals North America, Inc. (RozeremTM (ramelteon)
Tablets)
-
Takeda Pharmaceuticals North America, Inc. (Actos (pioglitazone
hydrochloride) Tablets)
TAP
Holdings/Pharmaceutical Products, Inc.
-
TAP
Pharmaceutical Products, Inc. (Prevacid (lansoprazole) Delayed Release
Capsules)
-
TAP Pharmaceutical
Products, Inc. (Uprima (apomorphine HCl tablets) sublingual )
-
TAP Holdings Inc. (Prevacid
(lansoprazole) Delayed Release Capsules )
Taro Pharmaceuticals U.S.A., Inc.
- Taro
Pharmaceuticals U.S.A., Inc. (Inspection of Manufacturing Facility)
ThermoLife
International
-
ThermoLife International
(Lipodryl II)
Tianjin
Xin Xin Pharmaceutical Corporation
-
Tianjin
Xin Xin Pharmaceutical Corporation (Site Inspection
Tomita Pharmaceutical Co., Ltd
-
Tomita Pharmaceutical Co., Ltd (Site Inspection)
Travanti Pharma, Inc.
-
Travanti Pharma, Inc. (Clinical Investigation)
UCLA David Geffen School of Medicine
- UCLA David
Geffen School of Medicine (Clinical Investigation)
Underwood, Hollis J.C. M.D.
-
Hollis J.C. Underwood, M.D. (BMIS Inspection)
Unimed
Pharmaceuticals
- Unimed Pharmaceuticals, Inc.
(Anadrol-50 (oxymetholone) tablets)
United Therapeutics Corporation
- United
Therapeutics Corporation (Remodulin® (treprostinil sodium) Injection)
University of Illinois
-
University Of Illinois (Clinical Study)
University of Texas Southwestern Medical Center
- University
of Texas Southwestern Medical Center (BMIS Inspection)
Utah Valley Institute of Cystic Fibrosis
- Utah Valley
Institute of Cystic Fibrosis (Clinical Study)
VaxGen, Inc.
- VaxGen,
Inc. (Anthrax Vaccine)
Victory Pharma, Inc.
-
Victory Pharma, Inc. (Xodol (hydrocodone bitartrate and acetaminophen)
tablets)
Vivus Inc.
-
VIVUS, Inc.
(MUSE (alprostadil) Urethral Suppository)
-
Vivus
Inc. (MUSE (alprostadil) urethral suppository)
Watson
Laboratories, Inc.
-
Watson
Pharmaceuticals, Inc. (Ferrlecit (sodium ferric gluconate complex in
sucrose injection))
-
Watson Laboratories,
Inc. (Norco (hydrocodone bitartrate and acetaminophen tablets, USP))
WellSpring Pharmaceutical Corporation
-
WellSpring Pharmaceutical Corporation (Dyrenium® (triamterene) Capsules)
WIL Research
Laboratories Inc.
-
WIL
Research Laboratories Inc. (Site Inspection)
Wockhardt Ltd.
-
Wockhardt Ltd. (Site Inspection)
Women's Capital Corporation
-
Women's Capital Corporation (Plan B (levonorgestrel) Tablets, 0.75 mg)
Women’s
Cancer Center of Nevada
-
Women’s Cancer Center of Nevada (Clinical Investigation)
Wyeth Pharmaceuticals, Inc./Wyeth-Ayerst Laboratories/Wyeth-Ayerst Research
-
Wyeth
Pharmaceuticals, Inc. (Effexor XR© (venlafaxine HCI)
Tablets)
-
Wyeth
Pharmaceuticals (Effexor, Effexor XR)
-
Wyeth-Ayerst Laboratories (Suprax (cefixime) Oral)
-
Wyeth-Ayerst
(Protonix Injection and Delayed-Release Tablets)
-
Wyeth-Ayerst (Effexor
XR (venlafaxine) Extended Release Capsules)
-
Wyeth-Ayerst
Research (Sonata (zaleplon) Capsules)
Xanodyne Pharmacal, Inc.
- Xanodyne Pharmacal, Inc.
(Methotrexate, Leucovorin, Amicar)
Xcel Pharmaceuticals
- Xcel
Pharmaceuticals (Migranal (Dihydroergotamine Mesylate) Nasal Spray &
D.H.E. 45 Injection)
Xinjiang
Pharmaceutical Factory
-
Xinjiang
Pharmaceutical Factory (Site Inspection)
Yung Shin
Pharm. Inc. Col, Ltd.
-
Yung Shin
Pharm. Inc. Col, Ltd. (Site Inspection)
Zaharowitz, Herman M.D.
-
Herman Zaharowitz, M.D. (Clinical Investigation)
Zila Pharmaceuticals, Inc.
- Zila
Pharmaceuticals, Inc. (Peridex® (chlorhexidine gluconate 0.12%) Oral
Rinse)
ZymoGenetics, Inc.
-
ZymoGenetics, Inc. (Recothrom™ (Thrombin, Topical (Recombinant)))

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