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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 200894

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE)
10MG/5ML;6.25MG/5ML
Marketing Status: Prescription
Active Ingredient: CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 10MG/5ML;6.25MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A200894
Product Number: 001
Approval Date: Apr 24, 2013
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status:  Prescription
Patent and Exclusivity Information
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