FDA Drug Application (091153) for ESZOPICLONE by ROXANE

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Application Number091153
Product Number001
FormTABLET;ORAL
Dosage1MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameESZOPICLONE
Active IngredientESZOPICLONE



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