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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) 200218 | 001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 阿莫西林;克拉霉素;兰索拉唑 | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | 500MG;500MG;30MG | ANI PHARMS | 2013-08-30 | No | No | DISCN | |
(ANDA) 065382 | 002 | CLARITHROMYCIN | CLARITHROMYCIN | 克拉霉素 | FOR SUSPENSION;ORAL | 250MG/5ML | SUN PHARM INDS LTD | 2007-08-30 | No | No | DISCN | |
(NDA) 050775 | 001 | BIAXIN XL | CLARITHROMYCIN | 克拉霉素 | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ABBVIE | 2000-03-03 | Yes | No | DISCN | |
(ANDA) 065145 | 001 | CLARITHROMYCIN | CLARITHROMYCIN | 克拉霉素 | TABLET, EXTENDED RELEASE;ORAL | 500MG | ACTAVIS LABS FL INC | 2004-06-24 | No | No | RX | AB |
(ANDA) 065250 | 001 | CLARITHROMYCIN | CLARITHROMYCIN | 克拉霉素 | TABLET, EXTENDED RELEASE;ORAL | 500MG | ANI PHARMS | 2005-08-25 | No | No | DISCN | |
(ANDA) 210459 | 001 | CLARITHROMYCIN | CLARITHROMYCIN | 克拉霉素 | TABLET;ORAL | 250MG | ALEMBIC | 2022-01-31 | No | No | RX | AB |
(ANDA) 202532 | 001 | CLARITHROMYCIN | CLARITHROMYCIN | 克拉霉素 | TABLET, EXTENDED RELEASE;ORAL | 500MG | LUPIN LTD | 2015-09-15 | No | No | DISCN | |
(ANDA) 203243 | 001 | CLARITHROMYCIN | CLARITHROMYCIN | 克拉霉素 | TABLET, EXTENDED RELEASE;ORAL | 500MG | MPP PHARMA | 2016-02-29 | No | No | RX | AB |
(ANDA) 065210 | 001 | CLARITHROMYCIN | CLARITHROMYCIN | 克拉霉素 | TABLET, EXTENDED RELEASE;ORAL | 1GM | RANBAXY | 2005-01-26 | No | No | DISCN | |
(ANDA) 065382 | 001 | CLARITHROMYCIN | CLARITHROMYCIN | 克拉霉素 | FOR SUSPENSION;ORAL | 125MG/5ML | SUN PHARM INDS LTD | 2007-08-30 | No | No | DISCN | |
(NDA) 050662 | 002 | BIAXIN | CLARITHROMYCIN | 克拉霉素 | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ABBVIE | 1991-10-31 | Yes | No | DISCN | |
(ANDA) 065283 | 002 | CLARITHROMYCIN | CLARITHROMYCIN | 克拉霉素 | FOR SUSPENSION;ORAL | 125MG/5ML | SANDOZ | 2007-09-04 | No | No | RX | |
(NDA) 050662 | 001 | BIAXIN | CLARITHROMYCIN | 克拉霉素 | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ABBVIE | 1991-10-31 | Yes | No | DISCN | |
(ANDA) 202588 | 001 | LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 阿莫西林;克拉霉素;兰索拉唑 | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | 500MG;500MG;30MG | SANDOZ | 2014-03-04 | No | No | RX | AB |
(NDA) 050757 | 001 | PREVPAC (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 阿莫西林;克拉霉素;兰索拉唑 | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TAKEDA PHARMS USA | 1997-12-02 | Yes | No | DISCN | |
(NDA) 050824 | 001 | OMECLAMOX-PAK | AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE | 阿莫西林;克拉霉素;奥美拉唑 | CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL | 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CUMBERLAND | 2011-02-08 | Yes | No | DISCN | |
(ANDA) 065266 | 002 | CLARITHROMYCIN | CLARITHROMYCIN | 克拉霉素 | TABLET;ORAL | 500MG | WOCKHARDT | 2006-05-31 | No | No | DISCN | |
(NDA) 050698 | 001 | BIAXIN | CLARITHROMYCIN | 克拉霉素 | FOR SUSPENSION;ORAL | 125MG/5ML | ABBVIE | 1993-12-23 | Yes | No | DISCN | |
(NDA) 050698 | 003 | BIAXIN | CLARITHROMYCIN | 克拉霉素 | FOR SUSPENSION;ORAL | 187MG/5ML | ABBVIE | 1998-09-30 | No | No | DISCN | |
(NDA) 050698 | 002 | BIAXIN | CLARITHROMYCIN | 克拉霉素 | FOR SUSPENSION;ORAL | 250MG/5ML | ABBVIE | 1993-12-23 | Yes | No | DISCN |