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Product Details for ANDA 207487

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: Yes
TE Code: AA
Application Number: A207487
Product Number: 001
Approval Date: Feb 21, 2017
Applicant Holder Full Name: ABHAI LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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