商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
BIAXIN | 050662 | 001 | NDA | CLARITHROMYCIN | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1991/10/31 | 1991/10/31 | ABBVIE | Discontinued |
BIAXIN | 050662 | 002 | NDA | CLARITHROMYCIN | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1991/10/31 | 1991/10/31 | ABBVIE | Discontinued |
BIAXIN XL | 050697 | 001 | NDA | CLARITHROMYCIN | TABLET;ORAL | 250MG | No | No | 1993/12/23 | -- | ABBVIE INC | Prescription |
BIAXIN XL | 050697 | 002 | NDA | CLARITHROMYCIN | TABLET;ORAL | 500MG | No | No | 1993/12/23 | -- | ABBVIE INC | Prescription |
BIAXIN | 050698 | 001 | NDA | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 125MG/5ML | Yes | No | 1993/12/23 | 1993/12/23 | ABBVIE | Discontinued |
BIAXIN | 050698 | 002 | NDA | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 250MG/5ML | Yes | No | 1993/12/23 | 1993/12/23 | ABBVIE | Discontinued |
BIAXIN | 050698 | 003 | NDA | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 187MG/5ML | No | No | 1993/12/23 | 1998/09/30 | ABBVIE | Discontinued |
BIAXIN XL | 050775 | 001 | NDA | CLARITHROMYCIN | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2000/03/03 | 2000/03/03 | ABBVIE | Discontinued |