FDA ANDA · ANDA211568
ISOTRETINOIN
Sponsor: ZYDUS PHARMS
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APPLICATION
ANDA211568
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-29
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ISOTRETINOINPrescription
ISOTRETINOIN 40MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 9AP
2026-08-21Labeling · Supplement 8 · standardAP
2026-02-09REMS · Supplement 4AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →