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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) 220073 | 001 | ELIQUIS SPRINKLEP | APIXABAN | 阿哌沙班 | FOR SUSPENSION;ORAL | 0.15MG | BRISTOL | 2025-04-17 | Yes | Yes | RX | |
(NDA) 220020 | 001 | YEZTUGO | LENACAPAVIR SODIUM | 来那帕韦钠 | TABLET;ORAL | EQ 300MG BASE | GILEAD SCIENCES INC | 2025-06-18 | Yes | Yes | RX | |
(NDA) 220018 | 001 | YEZTUGO | LENACAPAVIR SODIUM | 来那帕韦钠 | SOLUTION;SUBCUTANEOUS | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | GILEAD SCIENCES INC | 2025-06-18 | Yes | Yes | RX | |
(NDA) 219920 | 001 | AVGEMSI | GEMCITABINE HYDROCHLORIDE | 盐酸吉西他滨 | SOLUTION;INTRAVENOUS | EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) | AVYXA HOLDINGS | 2025-06-27 | Yes | Yes | RX | |
(NDA) 219920 | 002 | AVGEMSI | GEMCITABINE HYDROCHLORIDE | 盐酸吉西他滨 | SOLUTION;INTRAVENOUS | EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) | AVYXA HOLDINGS | 2025-06-27 | Yes | Yes | RX | |
(NDA) 219920 | 003 | AVGEMSI | GEMCITABINE HYDROCHLORIDE | 盐酸吉西他滨 | SOLUTION;INTRAVENOUS | EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) | AVYXA HOLDINGS | 2025-06-27 | Yes | Yes | RX | |
(ANDA) 219883 | 001 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 盐酸罗哌卡因 | SOLUTION;INJECTION | 40MG/20ML (2MG/ML) | ANTHEA PHARMA | 2025-03-21 | No | No | RX | AP |
(ANDA) 219883 | 002 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 盐酸罗哌卡因 | SOLUTION;INJECTION | 150MG/30ML (5MG/ML) | ANTHEA PHARMA | 2025-03-21 | No | No | RX | AP |
(ANDA) 219883 | 003 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 盐酸罗哌卡因 | SOLUTION;INJECTION | 200MG/20ML (10MG/ML) | ANTHEA PHARMA | 2025-03-21 | No | No | RX | AP |
(NDA) 219847 | 001 | ARYNTAP | LISDEXAMFETAMINE DIMESYLATE | 二甲磺酸利右苯丙胺 | SOLUTION;ORAL | 10MG/ML | AZURITY | 2025-06-16 | Yes | Yes | RX | |
(ANDA) 219777 | 001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 1GM/2ML (500MG/ML) | ASPIRO | 2025-05-28 | No | No | RX | AP |
(ANDA) 219777 | 002 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 5GM/10ML (500MG/ML) | ASPIRO | 2025-05-28 | No | No | RX | AP |
(ANDA) 219777 | 003 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 10GM/20ML (500MG/ML) | ASPIRO | 2025-05-28 | No | No | RX | AP |
(ANDA) 219777 | 004 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 25GM/50ML (500MG/ML) | ASPIRO | 2025-05-28 | No | No | RX | AP |
(ANDA) 219775 | 001 | ACETAZOLAMIDE SODIUM | ACETAZOLAMIDE SODIUM | 乙酰唑胺钠 | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | GLAND | 2025-06-17 | No | No | RX | AP |
(ANDA) 219767 | 001 | TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | 盐酸坦索罗辛 | CAPSULE;ORAL | 0.4MG | GRAVITI PHARMS | 2025-05-01 | No | No | RX | AB |
(NDA) 219713 | 001 | IBTROZIP | TALETRECTINIB ADIPATE | CAPSULE;ORAL | EQ 200MG BASE | NUVATION | 2025-06-11 | Yes | Yes | RX | ||
(ANDA) 219701 | 001 | SODIUM BICARBONATE | SODIUM BICARBONATE | 碳酸氢钠 | INJECTABLE;INJECTION | 1MEQ/ML | ANTHEA PHARMA | 2025-06-26 | No | No | RX | AP |
(ANDA) 219699 | 001 | LACOSAMIDE | LACOSAMIDE | 拉考沙胺 | SOLUTION;ORAL | 10MG/ML | AJENAT PHARMS | 2025-06-26 | No | No | RX | AA |
(ANDA) 219689 | 001 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | 盐酸胍法辛 | TABLET, EXTENDED RELEASE;ORAL | EQ 1MG BASE | RUBICON | 2025-04-15 | No | No | RX | AB |