| Isotretinoin Capsules USP | BluePoint Laboratories | Dr. Reddy's Laboratories Limited | 20260401 | 4 |
| Isotretinoin Capsules, USP 10 mg, 20 mg, 30 mg, 40 mg | Upsher-Smith Laboratories, LLC | Douglas Manufacturing Limited | 20260213 | 3 |
| These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982 | Upsher-Smith Laboratories, LLC | Douglas Manufacturing Limited | 20260213 | 4 |
| Isotretinoin Capsules USP | JG Pharma Inc. | Dr. Reddy's Laboratories Limited FTO-SEZ-Process Unit-02 | Reed-Lane Inc. | 20260130 | 3 |
| These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20251009 | 3 |
| These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982 | Actavis Pharma, Inc. | 20250722 | 20 |
| 245898e5-3a61-4d6a-8375-8b3a8b7364ac | Zydus Lifesciences Limited | 20250604 | 1 |
| These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20250505 | 1 |
| Isotretinoin Capsules USP | Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited FTO-SEZ-Process Unit-02 | Reed-Lane Inc. | 20250207 | 27 |
| 06c2459c-ff0f-6f53-e063-6394a90a518a | Galephar Pharmaceutical Research Inc. | 20241206 | 3 |
| d6ba7a44-ca13-e001-e053-2995a90afe0c | Galephar Pharmaceutical Research Inc. | Galephar Pharmaceutical Research Inc | 20241206 | 2 |
| Isotretinoin Capsules, USP Rx Only CAUSES BIRTH DEFECTS | Zydus Lifesciences Limited | 20241130 | 2 |
| Isotretinoin Capsules, USP | Mayne Pharma | 20240626 | 4 |
| b2cb63c9-f825-4991-9a2c-6260f1bbcc2c | Mylan Pharmaceuticals Inc. | 20240623 | 23 |
| These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982 | Sun Pharmaceutical Industries, Inc. | Galephar Pharmaceutical Research Inc. | 20240110 | 2 |
| Isotretinoin Capsules, USP 10 mg, 20 mg, 30 mg, 40 mg Rx Only | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC | 20231230 | 26 |
| Isotretinoin Capsules, USP Rx Only | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20230901 | 1 |
| These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982 | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC | 20230824 | 9 |
| These highlights do not include all the information needed to use ABSORICA/ABSORICA LD safely and effectively. See full prescribing information for ABSORICA/ABSORICA LD. ABSORICA ® (isotretinoin) capsules, for oral use ABSORICA LD ® (isotretinoin) capsules, for oral use Initial U.S. Approval: 1982 | Sun Pharmaceutical Industries, Inc. | Galephar Pharmaceutical Research Inc. | Ohm Laboratories Inc. | 20230612 | 18 |
| Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg | Akorn Operating Company LLC | Swiss Caps AG | Douglas Manufacturing Ltd | 20221219 | 14 |
| These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982 | Mayne Pharma | 20221103 | 4 |
| These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982 | Mayne Pharma | 20221103 | 2 |
| These highlights do not include all the information needed to use ISOTRETINOIN CAPSULES safely and effectively. See full prescribing information for ISOTRETINOIN CAPSULES. ISOTRETINOIN capsules, for oral use Initial U.S. Approval: 1982 | Upsher-Smith Laboratories, LLC | 20221024 | 5 |
| CLARAVIS ™ (isotretinoin capsules USP) | Teva Pharmaceuticals USA, Inc. | 20220831 | 18 |
| Isotretinoin Capsules USP | Physicians Total Care, Inc. | 20140822 | 1 |
| CLARAVIS™ (isotretinoin capsules USP) | Physicians Total Care, Inc. | 20140120 | 4 |
| Myorisan TM (isotretinoin capsules, USP) 10 mg, 20 mg, 40 mg | Physicians Total Care, Inc. | 20130102 | 2 |
| 0018861f-1b9b-431b-84ee-9d34aab615c3 | Physicians Total Care, Inc. | 20120625 | 5 |
| SOTRET ® ISOTRETINOIN CAPSULES | Ranbaxy Laboratories Inc. | 20061107 | 1 |