Drug Approval Package

 Mucinex D (Guaifenesin/Pseudoephedrine HCI) Extended Release Tablets
Company:  Adams Laboratories
Application No.:  021585
Approval Date: 6/22/2004

• 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) & Correspondence (PDF)  

Date created: December 012005

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