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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 | YEZTUGOP | LENACAPAVIR SODIUM | 来那帕韦钠 | TABLET;ORAL | EQ 300MG BASE | GILEAD SCIENCES INC | 2025-06-18 | Yes | Yes | RX | |
(NDA) 220018 | 001 | YEZTUGOP | 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 | |
(ANDA) 219939 | 001 | CARBAMAZEPINE | CARBAMAZEPINE | 卡马西平 | TABLET, EXTENDED RELEASE;ORAL | 100MG | ALEMBIC | 2025-07-25 | No | No | RX | AB |
(ANDA) 219939 | 002 | CARBAMAZEPINE | CARBAMAZEPINE | 卡马西平 | TABLET, EXTENDED RELEASE;ORAL | 200MG | ALEMBIC | 2025-07-25 | No | No | RX | AB |
(ANDA) 219939 | 003 | CARBAMAZEPINE | CARBAMAZEPINE | 卡马西平 | TABLET, EXTENDED RELEASE;ORAL | 400MG | ALEMBIC | 2025-07-25 | No | No | RX | AB |
(NDA) 219935 | 001 | FAMOTIDINE | FAMOTIDINE | 法莫替丁 | SOLUTION;INTRAVENOUS | 20MG/5ML (4MG/ML) | SAGENT | 2025-07-16 | Yes | Yes | RX | |
(NDA) 219935 | 002 | FAMOTIDINE | FAMOTIDINE | 法莫替丁 | SOLUTION;INTRAVENOUS | 40MG/10ML (4MG/ML) | SAGENT | 2025-07-16 | Yes | Yes | RX | |
(NDA) 219935 | 003 | FAMOTIDINE | FAMOTIDINE | 法莫替丁 | SOLUTION;INTRAVENOUS | 200MG/50ML (4MG/ML) | SAGENT | 2025-07-16 | 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 |
(ANDA) 219863 | 001 | FAMOTIDINE | FAMOTIDINE | 法莫替丁 | FOR SUSPENSION;ORAL | 40MG/5ML | MSN | 2025-07-24 | No | No | RX | AB |
(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 | |
(NDA) 219843 | 001 | ATMEKSI | METHOCARBAMOL | 美索巴莫 | SUSPENSION;ORAL | 750MG/5ML | ROSEMONT PHARMS | 2025-07-30 | Yes | Yes | RX | |
(NDA) 219839 | 001 | ZEGFROVYP | SUNVOZERTINIB | 舒沃替尼 | TABLET;ORAL | 150MG | DIZAL JIANGSU | 2025-07-02 | Yes | No | RX | |
(NDA) 219839 | 002 | ZEGFROVYP | SUNVOZERTINIB | 舒沃替尼 | TABLET;ORAL | 200MG | DIZAL JIANGSU | 2025-07-02 | Yes | Yes | RX |