FDA Drug Application (088764) for PROMETH VC W/ CODEINE by ACTAVIS MID ATLANTIC

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Application Number088764
Product Number001
FormSYRUP;ORAL
Dosage10MG/5ML;5MG/5ML;6.25MG/5ML
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NamePROMETH VC W/ CODEINE
Active IngredientCODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE



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