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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) 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| 醋酸甲羟孕酮 | INJECTABLE;INJECTION | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PFIZER | 1982-01-01 | Yes | No | DISCN | |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) 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| SOLUTION;INTRAMUSCULAR | 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRISTOL MYERS SQUIBB | 1982-01-01 | Yes | No | DISCN | |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) 009238 | 002 | PROGESTERONE | PROGESTERONE | 黄体酮 | INJECTABLE;INJECTION | 25MG/ML | LILLY | 1982-01-01 | No | No | DISCN | |
(NDA) 009238 | 001 | PROGESTERONE | PROGESTERONE | 黄体酮 | INJECTABLE;INJECTION | 50MG/ML | LILLY | 1982-01-01 | No | No | DISCN | |
(ANDA) 085686 | 001 | CURRETAB | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | TABLET;ORAL | 10MG | SOLVAY | 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 | |
(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 | |
(NDA) 011839 | 003 | PROVERA | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | TABLET;ORAL | 5MG | PFIZER | 1982-01-01 | Yes | No | RX | AB |
(NDA) 011839 | 004 | PROVERA | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | TABLET;ORAL | 10MG | PFIZER | 1982-01-01 | Yes | Yes | RX | AB |
(NDA) 017439 | 001 | HYDROXYPROGESTERONE CAPROATE | HYDROXYPROGESTERONE CAPROATE | 己酸羟孕酮 | INJECTABLE;INJECTION | 125MG/ML | ALLERGAN | 1982-01-01 | 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) 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| SOLUTION;INTRAMUSCULAR | 250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BRISTOL MYERS SQUIBB | 1982-01-01 | Yes | No | DISCN | |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) 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) 017553 | 001 | PROGESTASERT | PROGESTERONE | 黄体酮 | INSERT, EXTENDED RELEASE;INTRAUTERINE | 38MG | ALZA | 1982-01-01 | No | No | DISCN | |
(ANDA) 083242 | 001 | AMEN | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | TABLET;ORAL | 10MG | AMARIN PHARMS | 1982-01-01 | No | No | DISCN | |
(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) 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) 011839 | 001 | PROVERA | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | TABLET;ORAL | 2.5MG | PFIZER | 1982-01-01 | Yes | No | RX | AB |
(ANDA) 088484 | 001 | MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | TABLET;ORAL | 10MG | UPSHER SMITH LABS | 1984-07-26 | No | No | DISCN | |
(ANDA) 089386 | 001 | CYCRIN | MEDROXYPROGESTERONE ACETATE | 醋酸甲羟孕酮 | TABLET;ORAL | 10MG | ESI | 1987-09-09 | No | No | DISCN |