| 商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CYANOCOBALAMIN | 206503 | 001 | ANDA | CYANOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2015/12/11 | 2015/12/11 | SOMERSET THERAPS LLC | Prescription |
| BALSALAZIDE DISODIUM | 206529 | 001 | ANDA | BALSALAZIDE DISODIUM | TABLET;ORAL | 1.1GM | No | No | 2016/12/28 (TA) | -- | LUPIN LTD | None (Tentative Approval) |
| CYANOCOBALAMIN | 204829 | 001 | ANDA | CYANOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2017/06/05 | 2017/06/05 | PHARMOBEDIENT | Prescription |
| BALCOLTRA | 208612 | 001 | NDA | ETHINYL ESTRADIOL; LEVONORGESTREL | TABLET;ORAL | 0.02MG;0.1MG | Yes | Yes | 2018/01/09 | 2018/01/09 | AVION PHARMS | Prescription |
| CYANOCOBALAMIN | 209255 | 001 | ANDA | CYANOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2018/12/18 | 2018/12/18 | VITRUVIAS THERAP | Prescription |
| CYANOCOBALAMIN | 209429 | 001 | ANDA | CYANOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2018/12/18 | 2018/12/18 | SOMERSET THERAPS LLC | Prescription |
| BALVERSA | 212018 | 001 | NDA | ERDAFITINIB | TABLET;ORAL | 3MG | Yes | No | 2019/04/12 | 2019/04/12 | JANSSEN BIOTECH | Prescription |
| BALVERSA | 212018 | 002 | NDA | ERDAFITINIB | TABLET;ORAL | 4MG | Yes | No | 2019/04/12 | 2019/04/12 | JANSSEN BIOTECH | Prescription |
| BALVERSA | 212018 | 003 | NDA | ERDAFITINIB | TABLET;ORAL | 5MG | Yes | Yes | 2019/04/12 | 2019/04/12 | JANSSEN BIOTECH | Prescription |
| PREGABALIN | 091219 | 001 | ANDA | PREGABALIN | CAPSULE;ORAL | 25MG | No | No | 2019/07/19 | 2019/07/19 | TEVA PHARMS | Discontinued |
| PREGABALIN | 091219 | 002 | ANDA | PREGABALIN | CAPSULE;ORAL | 50MG | No | No | 2019/07/19 | 2019/07/19 | TEVA PHARMS | Discontinued |
| PREGABALIN | 091224 | 001 | ANDA | PREGABALIN | CAPSULE;ORAL | 75MG | No | No | 2019/07/19 | 2019/07/19 | TEVA PHARMS | Discontinued |
| PREGABALIN | 091224 | 002 | ANDA | PREGABALIN | CAPSULE;ORAL | 100MG | No | No | 2019/07/19 | 2019/07/19 | TEVA PHARMS | Discontinued |
| PREGABALIN | 091224 | 003 | ANDA | PREGABALIN | CAPSULE;ORAL | 150MG | No | No | 2019/07/19 | 2019/07/19 | TEVA PHARMS | Discontinued |
| PREGABALIN | 091224 | 004 | ANDA | PREGABALIN | CAPSULE;ORAL | 200MG | No | No | 2019/07/19 | 2019/07/19 | TEVA PHARMS | Discontinued |
| PREGABALIN | 091224 | 005 | ANDA | PREGABALIN | CAPSULE;ORAL | 225MG | No | No | 2019/07/19 | 2019/07/19 | TEVA PHARMS | Discontinued |
| PREGABALIN | 091224 | 006 | ANDA | PREGABALIN | CAPSULE;ORAL | 300MG | No | No | 2019/07/19 | 2019/07/19 | TEVA PHARMS | Discontinued |
| PREGABALIN | 203459 | 001 | ANDA | PREGABALIN | CAPSULE;ORAL | 25MG | No | No | 2019/07/19 | 2019/07/19 | ALEMBIC | Prescription |
| PREGABALIN | 203459 | 002 | ANDA | PREGABALIN | CAPSULE;ORAL | 50MG | No | No | 2019/07/19 | 2019/07/19 | ALEMBIC | Prescription |
| PREGABALIN | 203459 | 003 | ANDA | PREGABALIN | CAPSULE;ORAL | 75MG | No | No | 2019/07/19 | 2019/07/19 | ALEMBIC | Prescription |