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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
TOPAMAX | 020505 | 001 | NDA | TOPIRAMATE | TABLET;ORAL | 100MG | Yes | Yes | 1996/12/24 | 1996/12/24 | JANSSEN PHARMS | Prescription |
TOPAMAX | 020505 | 002 | NDA | TOPIRAMATE | TABLET;ORAL | 200MG | Yes | No | 1996/12/24 | 1996/12/24 | JANSSEN PHARMS | Prescription |
TOPAMAX | 020505 | 003 | NDA | TOPIRAMATE | TABLET;ORAL | 300MG | No | No | 1996/12/24 | 1996/12/24 | JANSSEN PHARMS | Discontinued |
TOPAMAX | 020505 | 004 | NDA | TOPIRAMATE | TABLET;ORAL | 25MG | Yes | No | 1996/12/24 | 1996/12/24 | JANSSEN PHARMS | Prescription |
TOPAMAX | 020505 | 005 | NDA | TOPIRAMATE | TABLET;ORAL | 50MG | Yes | No | 1996/12/24 | 1996/12/24 | JANSSEN PHARMS | Prescription |
TOPAMAX | 020505 | 006 | NDA | TOPIRAMATE | TABLET;ORAL | 400MG | No | No | 1996/12/24 | 1996/12/24 | JANSSEN PHARMS | Discontinued |
TOPAMAX | 020844 | 001 | NDA | TOPIRAMATE | CAPSULE;ORAL | 15MG | Yes | No | 1998/10/26 | 1998/10/26 | JANSSEN PHARMS | Prescription |
TOPAMAX | 020844 | 002 | NDA | TOPIRAMATE | CAPSULE;ORAL | 25MG | Yes | Yes | 1998/10/26 | 1998/10/26 | JANSSEN PHARMS | Prescription |
TOPAMAX SPRINKLE | 020844 | 003 | NDA | TOPIRAMATE | CAPSULE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1998/10/26 | 1998/10/26 | JANSSEN PHARMS | Discontinued |