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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
RETROVIR | 019655 | 001 | NDA | ZIDOVUDINE | CAPSULE;ORAL | 100MG | Yes | Yes | 1987/03/19 | 1987/03/19 | VIIV HLTHCARE | Prescription |
RETROVIR | 019910 | 001 | NDA | ZIDOVUDINE | SOLUTION;ORAL | 50MG/5ML | Yes | Yes | 1989/09/28 | 1989/09/28 | VIIV HLTHCARE | Prescription |
RETROVIR | 019951 | 001 | NDA | ZIDOVUDINE | INJECTABLE;INJECTION | 10MG/ML | Yes | Yes | 1990/02/02 | 1990/02/02 | VIIV HLTHCARE | Prescription |
RETROVIR | 020518 | 001 | NDA | ZIDOVUDINE | TABLET;ORAL | 200MG | No | No | 1995/12/19 | 1995/12/19 | VIIV HLTHCARE | Discontinued |
RETROVIR | 020518 | 002 | NDA | ZIDOVUDINE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1995/12/19 | 1996/10/04 | VIIV HLTHCARE | Discontinued |