| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LEUPROLIDE ACETATE | 074728 | 001 | ANDA | LEUPROLIDE ACETATE | SOLUTION;SUBCUTANEOUS | 14MG/2.8ML (1MG/0.2ML) | No | Yes | 1998/08/04 | 1998/08/04 | SANDOZ | Prescription |
| LEUPROLIDE ACETATE | 075471 | 001 | ANDA | LEUPROLIDE ACETATE | SOLUTION;SUBCUTANEOUS | 14MG/2.8ML (1MG/0.2ML) | No | No | 2000/10/25 | 2000/10/25 | MEITHEAL | Prescription |
| LEUPROLIDE ACETATE | 075721 | 001 | ANDA | LEUPROLIDE ACETATE | SOLUTION;SUBCUTANEOUS | 14MG/2.8ML (1MG/0.2ML) | No | No | 2001/11/29 | 2001/11/29 | GENZYME | Discontinued |
| LEUPROLIDE ACETATE | 078885 | 001 | ANDA | LEUPROLIDE ACETATE | SOLUTION;SUBCUTANEOUS | 14MG/2.8ML (1MG/0.2ML) | No | No | 2009/03/09 | 2009/03/09 | SUN PHARM | Prescription |
| LEUPROLIDE ACETATE FOR DEPOT SUSPENSION | 205054 | 001 | NDA | LEUPROLIDE ACETATE | FOR SUSPENSION;INTRAMUSCULAR | 22.5MG/VIAL | Yes | Yes | 2018/08/28 | 2018/08/28 | INVAGEN PHARMS | Prescription |
| LEUPROLIDE ACETATE | 213829 | 001 | ANDA | LEUPROLIDE ACETATE | SOLUTION;SUBCUTANEOUS | 14MG/2.8ML (1MG/0.2ML) | No | No | 2021/08/13 | 2021/08/13 | RK PHARMA | Prescription |
| LEUPROLIDE ACETATE | 212963 | 001 | ANDA | LEUPROLIDE ACETATE | SOLUTION;SUBCUTANEOUS | 14MG/2.8ML (1MG/0.2ML) | No | No | 2022/06/06 | 2022/06/06 | EUGIA PHARMA | Prescription |
| LEUPROLIDE ACETATE | 215336 | 001 | ANDA | LEUPROLIDE ACETATE | SOLUTION;SUBCUTANEOUS | 14MG/2.8ML (1MG/0.2ML) | No | No | 2022/10/28 | 2022/10/28 | AMNEAL | Prescription |
| LEUPROLIDE ACETATE | 217957 | 001 | ANDA | LEUPROLIDE ACETATE | SOLUTION;SUBCUTANEOUS | 14MG/2.8ML (1MG/0.2ML) | No | No | 2024/10/17 | 2024/10/17 | UBI | Prescription |