Drug Approval Package
Ellence (Epirubicin Hydrochloride) Injection
Company: Pharmacia & Upjohn Company
Application No.: 50-778
Approval Date: 9/15/1999
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Medical Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF) -
Chemistry Review(s) (PDF)
-
Pharmacology Review(s) (PDF)
-
Statistical Review(s) (PDF)
-
Microbiology Review(s) (PDF)