Drug Approval Package
-
Simvastatin Orally Disintegrating Tablets, 10 mg, 20 mg, 40 mg and 80 mg
Company: Synthon Pharmaceuticals, Inc.
NDA: 021961
Approval Date: 10/9/2007
- Approval Letter(s) (PDF)
- Printed Labeling (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: February 2, 2009
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-