Drug Approval Package

 Zomig-ZMT (Zolmitriptan) Orally Disintegrating Tablets
Company:  AstraZeneca Pharmaceutical LP
Application No.:  021231
Approval Date: 2/13/2001

• Approval Letter(s) (PDF)    

• Printed Labeling (PDF)    

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)    

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)    

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)    

• Administrative Document(s) & Correspondence (PDF)  

Date created: June 14, 2004

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.