FDA Drug Application (019675) for ZANTAC by GLAXO GRP LTD

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Application Number019675
Product Number001
FormSYRUP;ORAL
DosageEQ 15MG BASE/ML
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NameZANTAC
Active IngredientRANITIDINE HYDROCHLORIDE



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