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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) 200456 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | SOFGEN PHARMS | 2012-09-28 | No | No | RX | AB |
(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 | |
(ANDA) 205229 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | XIROMED | 2017-10-20 | No | No | RX | AB |
(ANDA) 205229 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | XIROMED | 2017-10-20 | No | No | RX | AB |
(NDA) 019781 | 001 | PROMETRIUM | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | ACERTIS PHARMS | 1998-05-14 | 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) 019781 | 003 | PROMETRIUM | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 300MG | ACERTIS PHARMS | 1999-10-15 | No | No | DISCN | |
(ANDA) 200456 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | SOFGEN PHARMS | 2012-09-28 | No | No | RX | AB |
(ANDA) 211285 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | EUGIA PHARMA | 2018-10-26 | No | No | RX | AB |
(ANDA) 211285 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | EUGIA PHARMA | 2018-10-26 | No | No | RX | AB |
(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| 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PFIZER | 1982-01-01 | Yes | No | DISCN | |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) 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 | |
(ANDA) 207724 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | AMNEAL PHARMS NY | 2017-09-07 | No | No | RX | AB |
(ANDA) 207724 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | AMNEAL PHARMS NY | 2017-09-07 | No | No | RX | AB |
(ANDA) 200900 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | BIONPHARMA | 2013-08-16 | No | No | RX | AB |
(ANDA) 200900 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | BIONPHARMA | 2013-08-16 | No | No | RX | AB |
(ANDA) 208801 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 100MG | DR REDDYS | 2017-02-28 | No | No | RX | AB |
(ANDA) 208801 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | CAPSULE;ORAL | 200MG | DR REDDYS | 2017-02-28 | No | No | RX | AB |