FDA ANDA · ANDA212333
ISOTRETINOIN
Sponsor: UPSHER SMITH LABS
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APPLICATION
ANDA212333
TYPE
ANDA
ORIGINAL APPROVAL
2021-09-21
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ISOTRETINOINPrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 20AP
2026-02-09REMS · Supplement 10AP
2023-03-24REMS · Supplement 8AP
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 →