Drug Approval Package
Cetrotide (Cetrorelix Acetate) Injection
Company: ASTA Medica, Inc.
Application No.: 21-197
Approval Date: 8/11/2000
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Chemistry Review(s) (PDF)
-
Pharmacology Review(s) (PDF)
-
Statistical Review(s) (PDF)
-
Microbiology Review(s) (PDF)
-
Administrative Document(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Date created: April 24, 2002
Note: Documents in PDF format require the Adobe Acrobat Reader®.