FDA Drug Application (091528) for HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE by NOVEL LABS INC

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Application Number091528
Product Number001
FormTABLET;ORAL
Dosage1.5MG;5MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NameHOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
Active IngredientHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE



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