Drug Approval Package
-
Sarafem (fluoxetine hydrochloride) Tablets
Company: Warner Chilcott Company, Inc.
NDA: 21860
Approval Date: 05/19/2006
- Approval Letter(s) (PDF)
- Approvable Letter(s) (PDF)
- Printed Labeling (PDF)
- Office Director Memo (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Administrative Document(s) and Correspondence (PDF)
Date created: September 5, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-