Drug Approval Package
-
Nifedipine
Extended-Release Tablets
Company: Mylan Pharmaceuticals, Inc.
Application No.: 75-108
Approval Date: 12/17/1999
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Medical Review(s) (PDF)
-
Chemistry Review(s) (PDF)
-
Bioequivalence Review(s) (PDF)
-
Correspondence (PDF)
Date created: August 23, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-