FDA ANDA · ANDA216633
ISOTRETINOIN
Sponsor: ZYDUS PHARMS
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APPLICATION
ANDA216633
TYPE
ANDA
ORIGINAL APPROVAL
2025-05-22
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ISOTRETINOINPrescription
ISOTRETINOIN 35MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 25MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 40MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 4AP
2026-02-09REMS · Supplement 1AP
2025-05-22UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →