FDA Application

Amiodarone Hydrochloride Tablets
Company:  Par Pharmaceutical, Inc.
Application No.:  75-188
Approval Date: 2/24/1999

• Approval Letter(s) (PDF)  

• Printed Labeling  (PDF)  

• Chemistry Review(s) (PDF)

• Bioequivalence Review(s) (PDF)

• Administrative Document(s) (PDF)  

• Correspondence (PDF)

Date created: November 20, 2001

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