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药智数据企业版注册数据库:增设了"联合申报"、"临床试验默认许可日期"等搜索条件,让搜索页面纬度更加全面,还有热点搜索和高级条件组合检索等检索功能 等你来体验!
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1.新增“有无专利”下拉检索,列表页红色标记P代表有专利。

PS:当使用专利到期时间检索时,“有无专利”默认为有。

2.新增“参比标准”一栏,标为“Yes”的为ANDA体内(in vivo)实验的对照品。

3.批准日期显示1982-01-01的,实际为1982-01-01之前。


更多参比制剂一次性进口信息

导出数据
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) 217639 001 ORSERDU ELACESTRANT DIHYDROCHLORIDE 依拉司群 TABLET;ORAL EQ 86MG BASE STEMLINE THERAP 2023-01-27 Yes No RX
(NDA) 217639 002 ORSERDU ELACESTRANT DIHYDROCHLORIDE 依拉司群 TABLET;ORAL EQ 345MG BASE STEMLINE THERAP 2023-01-27 Yes Yes RX
(NDA) 217415 001 DAPTOMYCIN DAPTOMYCIN 达托霉素 POWDER;INTRAVENOUS 350MG/VIAL XELLIA PHARMS APS 2023-01-30 Yes Yes RX
(NDA) 217415 002 DAPTOMYCIN DAPTOMYCIN 达托霉素 POWDER;INTRAVENOUS 500MG/VIAL XELLIA PHARMS APS 2023-01-30 Yes Yes RX
(ANDA) 217410 001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 盐酸氟奋乃静 TABLET;ORAL 1MG AJANTA PHARMA LTD 2023-01-05 No No RX AB
(ANDA) 217410 002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 盐酸氟奋乃静 TABLET;ORAL 2.5MG AJANTA PHARMA LTD 2023-01-05 No No RX AB
(ANDA) 217410 003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 盐酸氟奋乃静 TABLET;ORAL 5MG AJANTA PHARMA LTD 2023-01-05 No No RX AB
(ANDA) 217410 004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 盐酸氟奋乃静 TABLET;ORAL 10MG AJANTA PHARMA LTD 2023-01-05 No No RX AB
(ANDA) 217399 001 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 奥美沙坦酯 TABLET;ORAL 5MG MSN 2023-01-18 No No RX AB
(ANDA) 217399 002 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 奥美沙坦酯 TABLET;ORAL 20MG MSN 2023-01-18 No No RX AB
(ANDA) 217399 003 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 奥美沙坦酯 TABLET;ORAL 40MG MSN 2023-01-18 No No RX AB
(ANDA) 217069 001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 盐酸去氧肾上腺素 SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) MANKIND PHARMA 2022-08-30 No No RX AP1
(ANDA) 217069 002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 盐酸去氧肾上腺素 SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) MANKIND PHARMA 2022-08-30 No No RX AP1
(ANDA) 217069 003 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 盐酸去氧肾上腺素 SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) MANKIND PHARMA 2022-08-30 No No RX AP1
(ANDA) 217054 001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 盐酸双环胺 CAPSULE;ORAL 10MG TWI PHARMS 2022-12-27 No No RX AB
(ANDA) 217038 001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 酮咯酸氨丁三醇 TABLET;ORAL 10MG ZYDUS 2022-10-21 No No RX AB
(ANDA) 217029 001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE 硫酸妥布霉素 INJECTABLE;INJECTION EQ 1.2GM BASE/VIAL HAINAN POLY 2023-02-01 No No RX AP
(ANDA) 217027 001 DETROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 天冬氨酸苯丙胺;硫酸苯丙胺;糖酸右苯丙胺;硫酸右苯丙胺 CAPSULE, EXTENDED RELEASE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG GRANULES 2023-01-23 No No RX AB
(ANDA) 217027 002 DETROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 天冬氨酸苯丙胺;硫酸苯丙胺;糖酸右苯丙胺;硫酸右苯丙胺 CAPSULE, EXTENDED RELEASE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG GRANULES 2023-01-23 No No RX AB
(ANDA) 217027 003 DETROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 天冬氨酸苯丙胺;硫酸苯丙胺;糖酸右苯丙胺;硫酸右苯丙胺 CAPSULE, EXTENDED RELEASE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG GRANULES 2023-01-23 No No RX AB