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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
METHADOSE | 017116 | 002 | NDA | METHADONE HYDROCHLORIDE | CONCENTRATE;ORAL | 10MG/ML | Yes | Yes | 1973/03/14 | Approved Prior to Jan 1, 1982 | SPECGX LLC | Prescription |
METHADOSE | 040050 | 001 | ANDA | METHADONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No | 1993/04/15 | 1993/04/15 | SPECGX LLC | Discontinued |
METHADOSE | 040050 | 002 | ANDA | METHADONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No | 1993/04/15 | 1993/04/15 | SPECGX LLC | Discontinued |
METHADOSE | 074184 | 001 | ANDA | METHADONE HYDROCHLORIDE | TABLET, FOR SUSPENSION;ORAL | 40MG | No | No | 1993/04/29 | 1993/04/29 | SPECGX LLC | Prescription |