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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040613

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE)
1.5MG/5ML;5MG/5ML
Marketing Status: Discontinued
Active Ingredient: HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 1.5MG/5ML;5MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A040613
Product Number: 001
Approval Date: Feb 8, 2008
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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