Treats multiple inflammatory nodules with a diameter of 5 mm or greater. ANDA 212333, held by Upsher Smith Labs. Isotretinoin.
As of Nov 15, 2026, ANDA 212333 (Isotretinoin), held by Upsher Smith Labs, was first approved by FDA on Sep 21, 2021, with 6 approved supplements and 0 published complete response letters.
Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2021 | Original application | Approved |
| Isotretinoin10MG · capsule;oral | Isotretinoin | Rx |
| Isotretinoin20MG · capsule;oral | Isotretinoin | Rx |
| Isotretinoin30MG · capsule;oral | Isotretinoin | Rx |
| Oct 7, 2026 | Supplement 20REMS | Approved | None posted |
| Feb 9, 2026 | Supplement 10REMS | Approved | None posted |
| Mar 24, 2023 | Supplement 8REMS | Approved | None posted |
| Oct 6, 2022 | Supplement 6REMS | Approved | None posted |
| Aug 24, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 8, 2021 | Supplement 1REMS | Approved | None posted |
| Sep 21, 2021 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
