Drug Approval Package
Apokyn (Apomorhpine
Hydrochloride) Injection
Company: Bertek Pharmaceuticals, Inc.
Application No.: 021264
Approval Date: 4/20/2004
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical 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) -
Chemistry Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF) -
Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Date created: August 272004
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