FdaApplication

ANDA 216633

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Identifiers

Properties

PropertyValue
applicant_nameZYDUS PHARMACEUTICALS USA INC
application_typeANDA
approval_date2025-05-22

Products (6)

ProductActive ingredientStrengthDosage form
ISOTRETINOINISOTRETINOIN20MGCAPSULE;ORAL
ISOTRETINOINISOTRETINOIN30MGCAPSULE;ORAL
ISOTRETINOINISOTRETINOIN40MGCAPSULE;ORAL
ISOTRETINOINISOTRETINOIN10MGCAPSULE;ORAL
ISOTRETINOINISOTRETINOIN35MGCAPSULE;ORAL
ISOTRETINOINISOTRETINOIN25MGCAPSULE;ORAL

6 products