Drug Approval Package
-
Singulair (Montelukast Sodium)
Tablets
Company: Merck Research Laboratories
Application No.: 020829
Approval Date: 2/20/1998
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Medical Review(s) (PDF)
-
Chemistry Review(s) (PDF)
-
Environmental Assessment (PDF)
-
Pharmacology Review(s) (PDF)
-
Statistical Review(s) (PDF)
Date created: July 12, 2005
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-