| 2026-02-24 | Class II | Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactur | MYLAN PHARMACEUTICALS INC |
| 2024-03-28 | Class II | Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Phar | Teva Pharmaceuticals USA, Inc |
| 2019-10-16 | Class III | Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. D | Amneal Pharmaceuticals, Inc. |
| 2018-12-07 | Class III | Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: | Sun Pharmaceutical Industries, Inc. |
| 2017-05-22 | Class II | Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufa | Dr. Reddy's Laboratories, Inc. |
| 2017-05-22 | Class II | Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufa | Dr. Reddy's Laboratories, Inc. |
| 2017-05-22 | Class II | Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufa | Dr. Reddy's Laboratories, Inc. |
| 2017-05-22 | Class II | Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufa | Dr. Reddy's Laboratories, Inc. |
| 2017-02-15 | Class III | Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufa | Dr. Reddy's Laboratories, Inc. |
| 2017-02-15 | Class III | Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufa | Dr. Reddy's Laboratories, Inc. |
| 2017-02-15 | Class III | Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufa | Dr. Reddy's Laboratories, Inc. |
| 2016-08-29 | Class III | ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla | Dr. Reddy's Laboratories, Inc. |
| 2015-06-26 | Class II | Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured fo | Ranbaxy Inc. |