| 0245-0570 | Isotretinoin | Isotretinoin | Upsher-Smith Laboratories, LLC | ANDA |
| 0245-0571 | Isotretinoin | Isotretinoin | Upsher-Smith Laboratories, LLC | ANDA |
| 0245-0573 | Isotretinoin | Isotretinoin | Upsher-Smith Laboratories, LLC | ANDA |
| 0245-0575 | Isotretinoin | Isotretinoin | Upsher-Smith Laboratories, LLC | ANDA |
| 0378-6611 | Amnesteem | isotretinoin | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-6612 | Amnesteem | isotretinoin | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-6613 | Amnesteem | isotretinoin | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-6614 | Amnesteem | isotretinoin | Mylan Pharmaceuticals Inc. | ANDA |
| 0555-1054 | Claravis | Isotretinoin | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0555-1055 | Claravis | Isotretinoin | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0555-1056 | Claravis | Isotretinoin | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0555-1057 | Claravis | Isotretinoin | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0591-2433 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA |
| 0591-2434 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA |
| 0591-2435 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA |
| 0591-2436 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA |
| 0591-2451 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA |
| 0591-2501 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA |
| 0832-8301 | Isotretinoin | Isotretinoin | Upsher-Smith Laboratories, LLC | ANDA |
| 0832-8302 | Isotretinoin | Isotretinoin | Upsher-Smith Laboratories, LLC | ANDA |
| 0832-8303 | Isotretinoin | Isotretinoin | Upsher-Smith Laboratories, LLC | ANDA |
| 0832-8304 | Isotretinoin | Isotretinoin | Upsher-Smith Laboratories, LLC | ANDA |
| 10631-002 | Absorica LD | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 10631-003 | Absorica LD | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 10631-005 | Absorica LD | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 10631-007 | Absorica LD | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 10631-115 | Absorica | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 10631-116 | Absorica | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 10631-117 | Absorica | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 10631-118 | Absorica | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 10631-133 | Absorica | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 10631-134 | Absorica | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 55111-113 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-135 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-136 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-137 | ZENATANE | ISOTRETINOIN | Dr. Reddy's Laboratories Limited | ANDA |
| 57664-020 | Isotretinoin | Isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC |
| 57664-021 | Isotretinoin | Isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC |
| 57664-022 | Isotretinoin | Isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC |
| 57664-023 | Isotretinoin | Isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC |
| 57664-024 | Isotretinoin | Isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC |
| 57664-025 | Isotretinoin | Isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC |
| 59651-631 | ISOTRETINOIN | ISOTRETINOIN | Aurobindo Pharma Limited | ANDA |
| 59651-632 | ISOTRETINOIN | ISOTRETINOIN | Aurobindo Pharma Limited | ANDA |
| 59651-633 | ISOTRETINOIN | ISOTRETINOIN | Aurobindo Pharma Limited | ANDA |
| 59651-634 | ISOTRETINOIN | ISOTRETINOIN | Aurobindo Pharma Limited | ANDA |
| 59651-635 | ISOTRETINOIN | ISOTRETINOIN | Aurobindo Pharma Limited | ANDA |
| 59651-636 | ISOTRETINOIN | ISOTRETINOIN | Aurobindo Pharma Limited | ANDA |
| 68001-652 | ZENATANE | ISOTRETINOIN | BluePoint Laboratories | ANDA |
| 68001-653 | ZENATANE | ISOTRETINOIN | BluePoint Laboratories | ANDA |
| 68001-654 | ZENATANE | ISOTRETINOIN | BluePoint Laboratories | ANDA |
| 68001-655 | ZENATANE | ISOTRETINOIN | BluePoint Laboratories | ANDA |
| 68308-570 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA |
| 68308-571 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA |
| 68308-573 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA |
| 68308-575 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA |
| 68308-781 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA |
| 68308-782 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA |
| 68308-783 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA |
| 68308-784 | Isotretinoin | Isotretinoin | Mayne Pharma | ANDA |
| 69238-1017 | Isotretinoin | Isotretinoin | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1174 | Isotretinoin | Isotretinoin | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1175 | Isotretinoin | Isotretinoin | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1176 | Isotretinoin | Isotretinoin | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1254 | Isotretinoin | Isotretinoin | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1255 | Isotretinoin | Isotretinoin | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1256 | Isotretinoin | Isotretinoin | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1257 | Isotretinoin | Isotretinoin | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1258 | Isotretinoin | Isotretinoin | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1259 | Isotretinoin | Isotretinoin | Amneal Pharmaceuticals NY LLC | ANDA |
| 70710-1022 | Isotretinoin | Isotretinoin | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1023 | Isotretinoin | Isotretinoin | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1024 | Isotretinoin | Isotretinoin | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1025 | Isotretinoin | Isotretinoin | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1574 | Isotretinoin | Isotretinoin | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1575 | Isotretinoin | Isotretinoin | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1576 | Isotretinoin | Isotretinoin | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1577 | Isotretinoin | Isotretinoin | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1578 | Isotretinoin | Isotretinoin | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1579 | Isotretinoin | Isotretinoin | Zydus Pharmaceuticals USA Inc. | ANDA |
| 10631-004 | Absorica LD | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |
| 10631-006 | Absorica LD | isotretinoin | Sun Pharmaceutical Industries, Inc. | NDA |