FDA Drug Application (040882) for PROMETHAZINE HYDROCHLORIDE by AMNEAL PHARMS

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Application Number040882
Product Number001
FormSYRUP;ORAL
Dosage6.25MG/5ML
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NamePROMETHAZINE HYDROCHLORIDE
Active IngredientPROMETHAZINE HYDROCHLORIDE



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