Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 008306

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PHENERGAN VC W/ CODEINE (CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE)
10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PHENERGAN VC W/ CODEINE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N008306
Product Number: 005
Approval Date: Apr 2, 1984
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PHENERGAN W/ CODEINE (CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE)
10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PHENERGAN W/ CODEINE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N008306
Product Number: 004
Approval Date: Apr 2, 1984
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information