Drug Approval Package

Sulfamethoxazole & Trimethoprim Tablets, USP & Phenazopyridine Hydrochloride Tablets, USP
Company:  Able Laboratories Inc.
Application No.:  21-105
Approval Date: 6/26/2001

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s)

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)

Date created: November 07, 2001

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