Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040838

HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN; HYDROCODONE BITARTRATE)
325MG/15ML;7.5MG/15ML Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 325MG/15ML;7.5MG/15ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A040838
Product Number: 001
Approval Date: May 10, 2013
Applicant Holder Full Name: PHARMACEUTICAL ASSOCIATES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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