APPLICATION
ANDA205063
TYPE
ANDA
ORIGINAL APPROVAL
2021-03-31
LATEST ACTION
2026-02-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ISOTRETINOINPrescription
ISOTRETINOIN 40MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 35MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 25MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL
Approval history
2026-02-09REMS · Supplement 10AP
2025-06-18Labeling · Supplement 11 · standardAP
2025-06-03Labeling · Supplement 8 · standardAP
2023-03-24REMS · Supplement 5AP
2022-10-06REMS · Supplement 4AP
2021-10-08REMS · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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