FDA ANDA · ANDA213571
ISOTRETINOIN
Sponsor: UPSHER SMITH LABS
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APPLICATION
ANDA213571
TYPE
ANDA
ORIGINAL APPROVAL
2021-04-12
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ISOTRETINOINPrescription
ISOTRETINOIN 40MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 19AP
2026-06-16Labeling · Supplement 11 · standardAP
2026-02-09REMS · Supplement 9AP
2023-03-24REMS · Supplement 7AP
2022-10-06REMS · Supplement 6AP
2022-08-24Labeling · Supplement 3 · standardAP
2021-10-08REMS · Supplement 1AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →