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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(NDA) 210132 | 002 | BIJUVAP | ESTRADIOL; PROGESTERONE | 雌二醇;黄体酮 | CAPSULE;ORAL | 0.5MG;100MG | MAYNE PHARMA | 2021-12-28 | Yes | No | RX | |
(NDA) 016911 | 002 | DELALUTIN | HYDROXYPROGESTERONE CAPROATE | 己酸羟孕酮 | SOLUTION;INTRAMUSCULAR | 250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRISTOL MYERS SQUIBB | 1982-01-01 | Yes | No | DISCN | |
(NDA) 201110 | 001 | MILPROSAP | PROGESTERONE | 黄体酮 | SYSTEM;VAGINAL | 1.78GM | FERRING PHARMS INC | 2020-04-29 | Yes | No | DISCN | |
(NDA) 011839 | 003 | PROVERA | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | TABLET;ORAL | 5MG | PFIZER | 1982-01-01 | Yes | No | RX | AB |
(NDA) 012541 | 003 | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 400MG/ML | PFIZER | 1982-01-01 | Yes | No | DISCN | |
(NDA) 017362 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | INJECTABLE;INJECTION | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ACTAVIS LABS UT INC | 1982-01-01 | Yes | No | DISCN | |
(NDA) 019781 | 001 | PROMETRIUM | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | ACERTIS PHARMS | 1998-05-14 | Yes | No | RX | AB |
(NDA) 019781 | 002 | PROMETRIUM | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | ACERTIS PHARMS | 1999-10-15 | Yes | Yes | RX | AB |
(NDA) 010347 | 004 | DELALUTIN | HYDROXYPROGESTERONE CAPROATE | 己酸羟孕酮 | SOLUTION;INTRAMUSCULAR | 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRISTOL MYERS SQUIBB | 1982-01-01 | Yes | No | DISCN | |
(NDA) 016911 | 001 | DELALUTIN | HYDROXYPROGESTERONE CAPROATE | 己酸羟孕酮 | SOLUTION;INTRAMUSCULAR | 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRISTOL MYERS SQUIBB | 1982-01-01 | Yes | No | DISCN | |
(NDA) 022057 | 001 | ENDOMETRIN | PROGESTERONE | 黄体酮 | INSERT;VAGINAL | 100MG | FERRING | 2007-06-21 | Yes | Yes | RX | |
(NDA) 210132 | 001 | BIJUVAP | ESTRADIOL; PROGESTERONE | 雌二醇;黄体酮 | CAPSULE;ORAL | 1MG;100MG | MAYNE PHARMA | 2018-10-28 | Yes | Yes | RX | |
(NDA) 020701 | 002 | CRINONE | PROGESTERONE | 黄体酮 | GEL;VAGINAL | 8% | ABBVIE | 1997-07-31 | Yes | Yes | RX | |
(NDA) 012541 | 002 | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PFIZER | 1982-01-01 | Yes | No | DISCN | |
(NDA) 021583 | 001 | DEPO-SUBQ PROVERA 104 | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | INJECTABLE;SUBCUTANEOUS | 104MG/0.65ML | PFIZER | 2004-12-17 | Yes | Yes | RX | |
(NDA) 010347 | 002 | DELALUTIN | HYDROXYPROGESTERONE CAPROATE | 己酸羟孕酮 | SOLUTION;INTRAMUSCULAR | 250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRISTOL MYERS SQUIBB | 1982-01-01 | Yes | No | DISCN | |
(NDA) 011839 | 001 | PROVERA | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | TABLET;ORAL | 2.5MG | PFIZER | 1982-01-01 | Yes | No | RX | AB |
(NDA) 020246 | 001 | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 150MG/ML | PFIZER | 1992-10-29 | Yes | Yes | RX | AB |
(NDA) 020874 | 001 | LUNELLE | ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE | 环戊丙酸雌二醇;醋酸甲羟孕酮 | INJECTABLE;INTRAMUSCULAR | 5MG/0.5ML;25MG/0.5ML | PHARMACIA AND UPJOHN | 2000-10-05 | Yes | No | DISCN | |
(NDA) 020701 | 001 | CRINONE | PROGESTERONE | 黄体酮 | GEL;VAGINAL | 4% | ABBVIE | 1997-07-31 | Yes | Yes | RX |