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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) 219016 | 001 | EDURANT PED | RILPIVIRINE HYDROCHLORIDE | 利匹韦林 | TABLET, FOR SUSPENSION;ORAL | EQ 2.5MG BASE | JANSSEN PRODS | 2024-03-15 | Yes | Yes | RX | |
(ANDA) 218615 | 001 | SUNITINIB MALATE | SUNITINIB MALATE | 苹果酸舒尼替尼 | CAPSULE;ORAL | EQ 12.5MG BASE | EUGIA PHARMA | 2024-03-14 | No | No | RX | AB |
(ANDA) 218615 | 002 | SUNITINIB MALATE | SUNITINIB MALATE | 苹果酸舒尼替尼 | CAPSULE;ORAL | EQ 25MG BASE | EUGIA PHARMA | 2024-03-14 | No | No | RX | AB |
(ANDA) 218615 | 003 | SUNITINIB MALATE | SUNITINIB MALATE | 苹果酸舒尼替尼 | CAPSULE;ORAL | EQ 37.5MG BASE | EUGIA PHARMA | 2024-03-14 | No | No | RX | AB |
(ANDA) 218615 | 004 | SUNITINIB MALATE | SUNITINIB MALATE | 苹果酸舒尼替尼 | CAPSULE;ORAL | EQ 50MG BASE | EUGIA PHARMA | 2024-03-14 | No | No | RX | AB |
(ANDA) 218603 | 001 | MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | 麦考酚钠 | TABLET, DELAYED RELEASE;ORAL | EQ 180MG BASE | AUROBINDO PHARMA LTD | 2024-02-27 | No | No | RX | AB |
(ANDA) 218603 | 002 | MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | 麦考酚钠 | TABLET, DELAYED RELEASE;ORAL | EQ 360MG BASE | AUROBINDO PHARMA LTD | 2024-02-27 | No | No | RX | AB |
(NDA) 218550 | 001 | ROZLYTREK | ENTRECTINIB | 恩曲替尼 | PELLETS;ORAL | 50MG/PACKET | GENENTECH INC | 2023-10-20 | Yes | Yes | RX | |
(ANDA) 218533 | 001 | VORICONAZOLE | VORICONAZOLE | 伏立康唑 | INJECTABLE;INTRAVENOUS | 200MG/VIAL | ASPIRO | 2024-04-03 | No | No | RX | AP |
(NDA) 218490 | 001 | OPSYNVI | MACITENTAN; TADALAFIL | TABLET;ORAL | 10MG;20MG | ACTELION | 2024-03-22 | Yes | No | RX | ||
(NDA) 218490 | 002 | OPSYNVI | MACITENTAN; TADALAFIL | TABLET;ORAL | 10MG;40MG | ACTELION | 2024-03-22 | Yes | Yes | RX | ||
(ANDA) 218467 | 001 | SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 100MG/5ML (20MG/ML) | DR REDDYS | 2024-01-17 | No | No | RX | AP | |
(ANDA) 218461 | 001 | FAMOTIDINE | FAMOTIDINE | 法莫替丁 | TABLET;ORAL | 10MG | GRAVITI PHARMS | 2024-03-14 | No | No | OTC | |
(ANDA) 218461 | 002 | FAMOTIDINE | FAMOTIDINE | 法莫替丁 | TABLET;ORAL | 20MG | GRAVITI PHARMS | 2024-03-14 | No | No | OTC | |
(ANDA) 218448 | 001 | DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 盐酸苯海拉明 | INJECTABLE;INJECTION | 50MG/ML | GLAND PHARMA LTD | 2024-03-20 | No | No | RX | AP |
(ANDA) 218412 | 001 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 盐酸去氧肾上腺素 | SOLUTION;INTRAVENOUS | 10MG/ML (10MG/ML) | HAINAN POLY | 2024-03-14 | No | No | RX | AP1 |
(ANDA) 218412 | 002 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 盐酸去氧肾上腺素 | SOLUTION;INTRAVENOUS | 50MG/5ML (10MG/ML) | HAINAN POLY | 2024-03-14 | No | No | RX | AP1 |
(ANDA) 218412 | 003 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 盐酸去氧肾上腺素 | SOLUTION;INTRAVENOUS | 100MG/10ML (10MG/ML) | HAINAN POLY | 2024-03-14 | No | No | RX | AP1 |
(ANDA) 218404 | 001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 盐酸纳洛酮 | INJECTABLE;INJECTION | 0.4MG/ML | MANKIND PHARMA | 2024-02-29 | No | No | RX | AP |
(ANDA) 218371 | 001 | HALOPERIDOL | HALOPERIDOL LACTATE | 乳酸氟哌啶醇 | CONCENTRATE;ORAL | EQ 2MG BASE/ML | RUBICON | 2024-01-31 | No | No | RX | AA |