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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 | |
(ANDA) 217707 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | INJECTABLE;INJECTION | 50MG/ML | ACCORD HLTHCARE | 2023-11-21 | No | No | DISCN | |
(ANDA) 202121 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | TEVA PHARMS | 2012-02-29 | No | No | DISCN | |
(ANDA) 202121 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | TEVA PHARMS | 2012-02-29 | No | No | DISCN | |
(NDA) 017439 | 001 | HYDROXYPROGESTERONE CAPROATE | HYDROXYPROGESTERONE CAPROATE | 己酸羟孕酮 | INJECTABLE;INJECTION | 125MG/ML | ALLERGAN | 1982-01-01 | No | No | DISCN | |
(NDA) 017439 | 002 | HYDROXYPROGESTERONE CAPROATE | HYDROXYPROGESTERONE CAPROATE | 己酸羟孕酮 | INJECTABLE;INJECTION | 250MG/ML | ALLERGAN | 1982-01-01 | No | No | DISCN | |
(ANDA) 210335 | 001 | MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 150MG/ML | CIPLA | 2019-01-25 | No | No | DISCN | |
(ANDA) 214309 | 001 | MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 150MG/ML | HIKMA | 2023-01-05 | No | No | DISCN | |
(NDA) 019781 | 003 | PROMETRIUM | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 300MG | ACERTIS PHARMS | 1999-10-15 | No | No | DISCN | |
(ANDA) 076552 | 001 | MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 150MG/ML | TEVA PHARMS USA | 2004-10-27 | No | No | DISCN | |
(ANDA) 210760 | 001 | MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 150MG/ML | SUN PHARM | 2019-05-01 | No | No | DISCN | |
(ANDA) 078711 | 001 | MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 150MG/ML | SANDOZ | 2009-05-20 | No | No | DISCN | |
(NDA) 210132 | 001 | BIJUVAP | ESTRADIOL; PROGESTERONE | 雌二醇;黄体酮 | CAPSULE;ORAL | 1MG;100MG | MAYNE PHARMA | 2018-10-28 | Yes | Yes | RX | |
(ANDA) 214293 | 001 | ESTRADIOL AND PROGESTERONE | ESTRADIOL; PROGESTERONE | 雌二醇;黄体酮 | CAPSULE;ORAL | 1MG;100MG | AMNEAL PHARMS | 2022-05-16 | No | No | DISCN | |
(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 | |
(ANDA) 210761 | 001 | MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 150MG/ML | SUN PHARM | 2019-04-24 | No | No | DISCN | |
(NDA) 020303 | 001 | PREMPRO (PREMARIN;CYCRIN) | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | 结合雌激素;醋酸甲羟孕酮 | TABLET;ORAL-28 | 0.625MG,0.625MG;2.5MG,2.5MG | WYETH PHARMS INC | 1994-12-30 | No | No | DISCN | |
(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) 018004 | 001 | HYDROXYPROGESTERONE CAPROATE | HYDROXYPROGESTERONE CAPROATE | 己酸羟孕酮 | INJECTABLE;INJECTION | 125MG/ML | EPIC PHARMA LLC | 1982-01-01 | No | No | DISCN |