Drug Approval Package

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3400 for assistance.

Approval Letter(s) (PDF)
Printed Labeling (PDF)
Medical Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
- Part 4 (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
- Part 4 (PDF)
- Part 5 (PDF)
- Part 6 (PDF)
- Part 7 (PDF)
- Part 8 (PDF)
- Part 9 (PDF)
- Part 10 (PDF)
- Part 11 (PDF)
- Part 12 (PDF)
- Part 13 (PDF)
- Part 14 (PDF)
- Part 15 (PDF)
- Part 16 (PDF)
- Part 17 (PDF)
- Part 18 (PDF)
- Part 19 (PDF)
- Part 20 (PDF)
- Part 21 (PDF)
- Part 22 (PDF)
- Part 23 (PDF)
- Part 24 (PDF)
Statistical Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
Clinical Pharmacology Biopharmaceutics Review(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
Administrative Document(s)
- Part 1 (PDF)
- Part 2 (PDF)
- Part 3 (PDF)
- Part 4 (PDF)
- Part 5 (PDF)
- Part 6 (PDF)
- Part 7 (PDF)
- Part 8 (PDF)
- Part 9 (PDF)
- Part 10 (PDF)

Date created: June 18, 2001

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