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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
MOUNJARO (AUTOINJECTOR) | 215866 | 001 | NDA | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | Yes | Yes | 2022/05/13 | 2022/05/13 | ELI LILLY AND CO | Prescription |
MOUNJARO (AUTOINJECTOR) | 215866 | 002 | NDA | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | Yes | Yes | 2022/05/13 | 2022/05/13 | ELI LILLY AND CO | Prescription |
MOUNJARO (AUTOINJECTOR) | 215866 | 003 | NDA | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | Yes | Yes | 2022/05/13 | 2022/05/13 | ELI LILLY AND CO | Prescription |
MOUNJARO (AUTOINJECTOR) | 215866 | 004 | NDA | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | Yes | Yes | 2022/05/13 | 2022/05/13 | ELI LILLY AND CO | Prescription |
MOUNJARO (AUTOINJECTOR) | 215866 | 005 | NDA | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | Yes | Yes | 2022/05/13 | 2022/05/13 | ELI LILLY AND CO | Prescription |
MOUNJARO (AUTOINJECTOR) | 215866 | 006 | NDA | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | Yes | Yes | 2022/05/13 | 2022/05/13 | ELI LILLY AND CO | Prescription |