FDA Drug Application (091128) for MONTELUKAST SODIUM by ROXANE

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Application Number091128
Product Number001
FormTABLET, CHEWABLE;ORAL
DosageEQ 4MG BASE
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameMONTELUKAST SODIUM
Active IngredientMONTELUKAST SODIUM



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