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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 088896

PROMETHAZINE VC W/ CODEINE (CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE)
10MG/5ML;5MG/5ML;6.25MG/5ML
Marketing Status: Discontinued
Active Ingredient: CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE VC W/ CODEINE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 10MG/5ML;5MG/5ML;6.25MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A088896
Product Number: 001
Approval Date: Jan 4, 1985
Applicant Holder Full Name: WOCKHARDT EU OPERATIONS (SWISS) AG
Marketing Status:  Discontinued
Patent and Exclusivity Information
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