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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205731

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE)
1.5MG/5ML;5MG/5ML
Marketing Status: Prescription
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: AA
Application Number: A205731
Product Number: 001
Approval Date: Feb 15, 2017
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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