Drug Approval Package

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Drug Approval Package

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Nalbuphine Hydrochloride Injection
Company: King Pharmaceuticals, Inc.
Application No.: ANDA 74-471
Approval Date: 3/19/98

Approval Letter, Final Printed Labeling, Chemistry Review(s), Bioequivalence Review(s), and Microbiology Review(s) (PDF) (1.1 MB)
Administrative Documents and Correspondence (PDF) (2.9 MB)

Last updated: June 30, 2005

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