FdaApplication

ANDA 206771

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Identifiers

Properties

PropertyValue
applicant_nameZYDUS PHARMACEUTICALS USA INC
application_typeANDA
approval_date2023-06-12

Products (2)

ProductActive ingredientStrengthDosage form
DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE;ORAL
DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE;ORAL

2 products