Drug Approval Package
-
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
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-