| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GANIRELIX ACETATE | 021057 | 001 | NDA | GANIRELIX ACETATE | INJECTABLE;INJECTION | 250MCG/0.5ML | Yes | Yes | 1999/07/29 | 1999/07/29 | ORGANON USA ORGANON | Prescription |
| GANIRELIX ACETATE | 212613 | 001 | ANDA | GANIRELIX ACETATE | INJECTABLE;INJECTION | 250MCG/0.5ML | No | No | 2022/04/07 | 2022/04/07 | AMPHASTAR PHARMS INC | Prescription |
| GANIRELIX ACETATE | 214996 | 001 | ANDA | GANIRELIX ACETATE | INJECTABLE;INJECTION | 250MCG/0.5ML | No | No | 2022/06/06 | 2022/06/06 | MEITHEAL | Prescription |
| GANIRELIX ACETATE | 215658 | 001 | ANDA | GANIRELIX ACETATE | INJECTABLE;INJECTION | 250MCG/0.5ML | No | No | 2023/02/28 | 2023/02/28 | GLAND PHARMA LTD | Prescription |
| GANIRELIX ACETATE | 216075 | 001 | ANDA | GANIRELIX ACETATE | INJECTABLE;INJECTION | 250MCG/0.5ML | No | No | 2023/11/16 | 2023/11/16 | LUPIN LTD | Prescription |