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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(ANDA) 218045 | 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | TABLET;ORAL | EQ 25MG BASE | CADILA PHARMS LTD | 2023-11-28 | No | No | RX | AB |
(ANDA) 218045 | 002 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | TABLET;ORAL | EQ 50MG BASE | CADILA PHARMS LTD | 2023-11-28 | No | No | RX | AB |
(ANDA) 218045 | 003 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | TABLET;ORAL | EQ 100MG BASE | CADILA PHARMS LTD | 2023-11-28 | No | No | RX | AB |
(ANDA) 218036 | 001 | LITHIUM CITRATE | LITHIUM CITRATE | 枸橼酸锂 | SYRUP;ORAL | EQ 300MG CARBONATE/5ML | RUBICON | 2023-08-14 | No | Yes | RX | AA |
(ANDA) 217511 | 001 | BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | 枸橼酸铋钾;甲硝唑;盐酸四环素 | CAPSULE;ORAL | 140MG;125MG;125MG | RICONPHARMA LLC | 2023-07-03 | No | No | RX | AB |
(ANDA) 217183 | 001 | LITHIUM CITRATE | LITHIUM CITRATE | 枸橼酸锂 | SYRUP;ORAL | EQ 300MG CARBONATE/5ML | SAPTALIS PHARMS | 2024-03-18 | No | No | RX | AA |
(ANDA) 216878 | 001 | TOFACITINIB CITRATE | TOFACITINIB CITRATE | 枸橼酸托法替布 | SOLUTION;ORAL | EQ 1MG BASE/ML | SLAYBACK PHARMA LLC | 2023-09-25 | No | No | RX | AA |
(ANDA) 216383 | 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | TABLET;ORAL | EQ 25MG BASE | NOVITIUM PHARMA | 2023-08-29 | No | No | RX | AB |
(ANDA) 216383 | 002 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | TABLET;ORAL | EQ 50MG BASE | NOVITIUM PHARMA | 2023-08-29 | No | No | RX | AB |
(ANDA) 216383 | 003 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | TABLET;ORAL | EQ 100MG BASE | NOVITIUM PHARMA | 2023-08-29 | No | No | RX | AB |
(ANDA) 216204 | 001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 枸橼酸苯海拉明;布洛芬 | TABLET;ORAL | 38MG;200MG | AUROBINDO PHARMA | 2022-05-31 | No | No | OTC | |
(NDA) 215870 | 001 | FENTANYL CITRATE | FENTANYL CITRATE | 枸橼酸芬太尼 | SOLUTION;INTRAVENOUS | EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) | EXELA PHARMA | 2023-02-08 | Yes | No | DISCN | |
(NDA) 215870 | 002 | FENTANYL CITRATE | FENTANYL CITRATE | 枸橼酸芬太尼 | SOLUTION;INTRAVENOUS | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | EXELA PHARMA | 2023-02-08 | Yes | No | DISCN | |
(ANDA) 215708 | 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | FOR SUSPENSION;ORAL | EQ 10MG BASE/ML | ZYDUS LIFESCIENCES | 2022-09-29 | No | No | RX | AB |
(ANDA) 215522 | 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | FOR SUSPENSION;ORAL | EQ 10MG BASE/ML | TARO | 2021-11-16 | No | No | RX | AB |
(NDA) 214952 | 001 | LIQREVP | SILDENAFIL CITRATE | 枸橼酸西地那非 | SUSPENSION;ORAL | EQ 10MG BASE/ML | CMP DEV LLC | 2023-04-28 | Yes | Yes | RX | |
(ANDA) 214773 | 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | FOR SUSPENSION;ORAL | EQ 10MG BASE/ML | AUROBINDO PHARMA LTD | 2022-12-23 | No | No | RX | AB |
(ANDA) 214641 | 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | FOR SUSPENSION;ORAL | EQ 10MG BASE/ML | MSN | 2022-02-08 | No | No | RX | AB |
(ANDA) 214556 | 001 | SILDENAFIL CITRATE | SILDENAFIL CITRATE | 枸橼酸西地那非 | FOR SUSPENSION;ORAL | EQ 10MG BASE/ML | GRANULES | 2023-12-01 | No | No | RX | AB |
(ANDA) 214426 | 001 | POTASSIUM CITRATE | POTASSIUM CITRATE | 枸橼酸钾 | TABLET, EXTENDED RELEASE;ORAL | 5MEQ | EYWA | 2021-02-19 | No | No | RX | AB |