Drug Approval Package
Mirapex (Pramipexole Dihydrochloride) Tablets
Company: Pharmacia & Upjohn, Inc.
Application No.: 020-667
Approval Date: 7/1/1997
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Approval Letter (PDF) (272 KB)
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Medical Review(s) (PDF)
Part 1 (3.1 MB)
Part 2 (2.5 MB)
Part 3 (2.9 MB)
Part 4 (2.4 MB)
Part 5 (3.3 MB)
Part 6 (3 MB)
Part 7 (2.8 MB)
Part 8 (2.8 MB)
Part 9 (2.8 MB)
Part 10 (2.8 MB)
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Chemistry Review(s) (PDF) (282 KB)
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Environmental Assessment (PDF) (2.3 MB)
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Pharmacology Review(s) (PDF)
Part 1 (3.1 MB)
Part 2 (2.5 MB)
Part 3 (2.9 MB)
Part 4 (2.4 MB)
Part 5 (3.3 MB)
Part 6 (3 MB)
Part 7 (2.8 MB)
Part 8 (2.8 MB)
Part 9 (2.8 MB) -
Statistical Review(s) (PDF) (1.5 MB)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (1.7 MB)
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Administrative Document(s) (PDF) (857 KB)
Date created: March 30, 2001; last updated: July 1, 2005
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