| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LUPRON DEPOT | 019732 | 001 | NDA | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 7.5MG | Yes | Yes | 1989/01/26 | 1989/01/26 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT | 020011 | 001 | NDA | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1990/10/22 | 1990/10/22 | ABBVIE ENDOCRINE INC | Discontinued |
| LUPRON DEPOT | 020011 | 002 | NDA | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 3.75MG | Yes | Yes | 1990/10/22 | 1995/10/26 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT-PED KIT | 020263 | 002 | NDA | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 7.5MG | Yes | Yes | 1993/04/16 | 1993/04/16 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT-PED KIT | 020263 | 003 | NDA | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1993/04/16 | 1993/04/16 | ABBVIE ENDOCRINE INC | Discontinued |
| LUPRON DEPOT-PED KIT | 020263 | 004 | NDA | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1993/04/16 | 1993/04/16 | ABBVIE ENDOCRINE INC | Discontinued |
| LUPRON DEPOT-PED KIT | 020263 | 005 | NDA | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 11.25MG | Yes | Yes | 1993/04/16 | 1994/01/21 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT-PED KIT | 020263 | 006 | NDA | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 15MG | Yes | Yes | 1993/04/16 | 1994/01/21 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT-PED KIT | 020263 | 007 | NDA | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 11.25MG | Yes | Yes | 1993/04/16 | 2011/08/15 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT-PED KIT | 020263 | 008 | NDA | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 30MG | Yes | Yes | 1993/04/16 | 2011/08/15 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT-PED KIT | 020263 | 009 | NDA | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 45MG | Yes | Yes | 1993/04/16 | 2023/04/14 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT | 019943 | 002 | NDA | LEUPROLIDE ACETATE | INJECTABLE; INJECTION | 3.75MG | No | No | 1995/03/30 | -- | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT | 020517 | 001 | NDA | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 22.5MG | Yes | No | 1995/12/22 | 1995/12/22 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT | 020517 | 002 | NDA | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 30MG | Yes | Yes | 1995/12/22 | 1997/05/30 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT | 020517 | 003 | NDA | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 45MG | Yes | Yes | 1995/12/22 | 2011/06/17 | ABBVIE ENDOCRINE INC | Prescription |
| LUPRON DEPOT | 020708 | 001 | NDA | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 11.25MG | Yes | Yes | 1997/03/07 | 1997/03/07 | ABBVIE ENDOCRINE INC | Prescription |