FDA Links -- Drug Information
 

1. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (5/14/2008)
    
2. Drugs@FDA Downloadable Data Files (updated 5/14/2008)
    
3. Drug Shortage: Digitek (digoxin tablets, USP) (5/12/2008)
    
4. Office of Generic Drugs: April First-Time Generic Drug Approvals (5/9/2008)
    
5. Office of Generic Drugs: March First-Time Generic Drug Approvals (4/18/1008)
    
6. Paragraph IV Patent Certifications (updated 4/15/2008)
    
7. The Adverse Event Reporting System (AERS) Latest Quarterly Data Files (updated 4/11/08)
    
8. New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated 4/10/2008)
    
9. Dissolution Methods Database (updated 4/9/2008)
    
10. Drugs@FDA Downloadable Data Files (updated 4/9/2008)
     
11. Drug Shortages (updated 4/7/2008)
    1. Current Drug Shortage: Neupro (rotigotine transdermal system)
    2. Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg
        
12. National Drug Code Directory Download (updated 4/4/2008)
     
13. National Drug Code Directory Search (updated 4/4/2008)
     
14. Resolved Drug Shortage: BiCNU (updated 4/2/2008)
     
15. Drugs@FDA Downloadable Data Files (updated 4/2/2008)
     
16. CDER Data Standards Manual: SPL Flavor (4/2/2008)
     
17. Dissolution Methods Database (updated 3/13/2008)
     
18. Approved Drug Products with Therapeutic Equivalence Evaluations: Orange Book (updated 3/13/2008)
     
19. Drug Approval Reports (updated 3/13/2008)
    1. NDA and BLA Approvals
    2. NME Drug and New Biologic Approvals
    3. Priority NDA and BLA Approvals
        
20. FDA updates screening method for heparin: Impurity Evaluation of Heparin Sodium by ¹H-NMR Spectroscopy (PDF, 3/11/2008)
     
21. National Drug Code Directory Download (updated 3/5/2008)
     
22. National Drug Code Directory Search (updated 3/5/2008)
     
23. Drug Safety Oversight Board Meeting, February 21, 2008, Public Summary (3/4/2008)
     
24. Drug Shortages (Update, 3/3/2008)
    1. Fentanyl transdermal patch
    2. Heparin sodium injection multidose and single dose vials, heparin flush products from Baxter
        
25. Drug Shortage (2/29/2008)
    1. Drug to be Discontinued: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection
        
26. Drug Shortage (2/28/2008)
    1. Drug to be Discontinued: Tenormin (atenolol) 0.5mg/ml Injection
        
27. Drug Shortages (Posted 2/26/2008)
    1. Drug to be Discontinued: Teslac (testolactone tablets, USP) 50mg tablets
        
28. Drug Shortages (updated 2/20/2008)
    1. Current Shortage: Baxter 1000u/mL heparin vials in 10mL and 30mL sizes
    2. Drug to be Discontinued: Zyflo (zileuton) tablets
        
29. Drugs@FDA Downloadable Data Files (updated 2/20/2008)
     
30. Acronyms and Abbreviations Database Download File (updated 2/15/2008)
     
31. Approved Drug Products with Therapeutic Equivalence Evaluations: Orange Book (updated 2/15/2008)
     
32. Duragesic (fentanyl transdermal system) Medication Guide (PDF, 2/13/2008)
     
33. Drug Approval Reports (2/12/2008)
    1. NDA and BLA Approvals (updated)
    2. NME Drug and New Biologic Approvals (updated)
    3. Priority NDA and BLA Approvals (updated)
    4. Efficacy Supplement Approvals (updated)
    5. New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated)
        
34. Office of Generic Drugs: January First-Time Generic Drug Approvals (updated 2/11/2008)
     
35. Adverse Event Reporting System (AERS) Latest Quarterly Data Files (2/7/2008)
     
36. Drug to be Discontinued: Humatin (Paromomycin Sulfate Capsules, USP) (2/7/2008)
     
37. Drug Shortage: Resolved; Tikosyn (0.5mg and 0.25mg capsules) (2/5/2008)
     
38. Drug Master Files (updated 1/29/2008)
     
39. Drug Shortages (1/23/2008)
    1. Current Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial containing EDTA
    2. Resolved Drug Shortage: Amytal (amobarbital sodium) injection Company Information
        
40. Inactive Ingredients for Approved Drug Products (Search) (updated 1/15/2008)
     
41. Inactive Ingredients for Approved Drug Products (Download) (updated 1/15/2008)
     
42. Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) (updated 1/15/2008)
     
43. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated 1/11/2008)
     
44. Bioresearch Monitoring Information System (BMIS) File (updated 1/11/2008)
     
45. Bioresearch Monitoring Information System (BMIS) Search (updated 1/11/2008)
     
46. National Drug Code Directory Download (updated 1/4/2008)
     
47. National Drug Code Directory Search (updated 1/4/2008)
     
48. Resolved Drug Shortage: Tc99: Multiple diagnostic products which utilize Tc99 generators (1/4/2008)
     
49. Office of Generic Drugs: November First-Time Generic Drug Approvals (updated 12/19/2007)
     
50. Adverse Drug Experience Reporting (updated 12/18/2007)
     
51. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection (12/14/2007)
     
52. Questions and Answers on Sapropterin (Kuvan) (12/13/2007)
     
53. Dissolution Methods Database (updated 12/5/2007)
     
54. Drug Shortage: Drug to be Discontinued; Roferon-A (Interferon alfa-2a, Recombinant) (11/29/2007)
     
55. Drugs@FDA Downloadable Data Files (updated 11/28/2007)
     
56. Drug Shortage: Resolved (11/21/2007)
    1. Indocyanine Green for Injection, USP (IC-GREEN)
    2. Solu-Cortef 100mg (hydrocortisone sodium succinate) for injection
        
57. Office of Generic Drugs: October First-Time Generic Drug Approvals (11/16/2007)
     
58. Drug Approval Reports (updated 11/14/2007)
    1. NDA and BLA Approvals
    2. NME Drug and New Biologic Approvals
    3. Priority NDA and BLA Approvals
        
59. Drug Approval Reports: Efficacy Supplement Approvals (11/13/2007)
     
60. Drug Shortage
    1. Drug to be Discontinued; Procanbid (Procanamide Hydrochloride Extended-Release Tablets) (11/9/2007)
        
61. Drug Approval Reports (Updated 11/9/2007)
    1. Fast Track Fiscal Year 2007
    2. Fast Track Designation (FY 1998 - FY 2006)
    3. NDA and BLA Approvals
    4. NME Drug and New Biologic Approvals
    5. Priority NDA and BLA Approvals
        
62. CellCept (mycophenolate mofetil) - Changes to prescribing information due to increased risk of first trimester pregnancy loss and increased risk of congenital malformations (10/29/2007)
     
63. Drug Shortage
    1. Drug to be Discontinued; Exubera (insulin recombinant human, powder for inhalation)
    2. Current Shortage: Valstar (valrubicin) Solution for Intravesical Instillation (updated 10/19/2007)
        
64. Paragraph IV Patent Certifications (updated 10/19/2007)
     
65. Bioresearch Monitoring Information System (BMIS) download file (Updated 10/18/2007)
     
66. Drug Approval Report: Accelerated Approvals (Updated 10/18/2007)
     
67. Office of Generic Drugs: First-Time Generic Drug Approvals (updated 10/17/2007)
     
68. AERS Quarterly Download, 2nd Quarter 2007 (updated 10/16/2007)
     
69. FDA Acronyms Search (updated 10/15/2007)
     
70. Dissolution Methods Database (updated 10/12/2007)
     
71. Drug Master Files (updated 10/12/2007)
     
72. Drug Shortage: Drug to be Discontinued; Sporanox (10/12/2007)
     
73. Drug Shortage: Drug to be Discontinued; Agenerase (amprenavir) 150mg capsule (updated 10/10/2007)
     
74. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
     
75. Drugs@FDA Downloadable Data Files (updated 10/10/2007)
     
76. Current Drug Shortage
    1. Solu-Cortef 100mg (Hydrocortisone sodium succinate) for injection (updated 10/9/2007)
    2. Valstar (valrubicin) Solution for Intravesical Instillation (updated 10/9/2007)
        
77. Prescription Drug User Fee Act (PDUFA) Billable Products (PDF, updated 9/28/2007)
     
78. Drug Shortage; Drug to be Discontinued; Ethmozine (moricizine hydrochloride) 200mg, 250g, and 300mg tablets (updated 9/17/2007)
     
79. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (9/13/2007)
     
80. Drug Safety Oversight Board Meeting Public Summaries for May and July (8/10/2007)