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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) 020701 | 002 | CRINONE | PROGESTERONE | 黄体酮 | GEL;VAGINAL | 8% | ABBVIE | 1997-07-31 | Yes | Yes | RX | |
(NDA) 020527 | 001 | PREMPRO | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | 结合雌激素;醋酸甲羟孕酮 | TABLET;ORAL-28 | 0.625MG;2.5MG | WYETH PHARMS | 1995-11-17 | Yes | Yes | RX | |
(NDA) 019781 | 002 | PROMETRIUM | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | ACERTIS PHARMS | 1999-10-15 | Yes | Yes | RX | AB |
(NDA) 020527 | 002 | PREMPHASE 14/14 | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | 结合雌激素;醋酸甲羟孕酮 | TABLET;ORAL-28 | 0.625MG,0.625MG;N/A,5MG | WYETH PHARMS | 1995-11-17 | Yes | Yes | RX | |
(NDA) 022057 | 001 | ENDOMETRIN | PROGESTERONE | 黄体酮 | INSERT;VAGINAL | 100MG | FERRING | 2007-06-21 | Yes | Yes | RX | |
(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) 020527 | 003 | PREMPRO | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | 结合雌激素;醋酸甲羟孕酮 | TABLET;ORAL-28 | 0.625MG;5MG | WYETH PHARMS | 1998-01-09 | Yes | Yes | RX | |
(NDA) 020527 | 004 | PREMPRO | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | 结合雌激素;醋酸甲羟孕酮 | TABLET;ORAL-28 | 0.45MG;1.5MG | WYETH PHARMS | 2003-03-12 | Yes | Yes | RX | |
(NDA) 011839 | 004 | PROVERA | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | TABLET;ORAL | 10MG | PFIZER | 1982-01-01 | Yes | Yes | RX | AB |
(ANDA) 210965 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | INJECTABLE;INJECTION | 50MG/ML | EUGIA PHARMA | 2018-12-06 | No | Yes | RX | AO |
(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) 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) 020527 | 005 | PREMPRO | ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE | 结合雌激素;醋酸甲羟孕酮 | TABLET;ORAL-28 | 0.3MG;1.5MG | WYETH PHARMS | 2003-06-04 | Yes | Yes | RX | |
(NDA) 020701 | 001 | CRINONE | PROGESTERONE | 黄体酮 | GEL;VAGINAL | 4% | ABBVIE | 1997-07-31 | Yes | Yes | RX | |
(ANDA) 202121 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | TEVA PHARMS | 2012-02-29 | No | No | DISCN | |
(ANDA) 202121 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | TEVA PHARMS | 2012-02-29 | No | No | DISCN | |
(ANDA) 200456 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | SOFGEN PHARMS | 2012-09-28 | No | No | RX | AB |
(ANDA) 200456 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | SOFGEN PHARMS | 2012-09-28 | No | No | RX | AB |
(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 | |
(ANDA) 200900 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | BIONPHARMA | 2013-08-16 | No | No | RX | AB |