FDA Drug Application (200540) for DICLOFENAC SODIUM AND MISOPROSTOL by EXELA PHARMA SCS LLC

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Application Number200540
Product Number001
FormTABLET, DELAYED RELEASE;ORAL
Dosage50MG;0.2MG
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameDICLOFENAC SODIUM AND MISOPROSTOL
Active IngredientDICLOFENAC SODIUM; MISOPROSTOL



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