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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ACYCLOVIR | 074570 | 002 | ANDA | ACYCLOVIR | CAPSULE;ORAL | 200MG | No | No | 1996/08/30 (TA) | 1997/04/22 | ROXANE | Discontinued |
ACYCLOVIR | 074750 | 001 | ANDA | ACYCLOVIR | CAPSULE;ORAL | 200MG | No | No | 1997/03/21 (TA) | 1997/04/22 | LEK PHARM | Discontinued |
ACYCLOVIR | 074658 | 001 | ANDA | ACYCLOVIR | TABLET;ORAL | 400MG | No | No | 1997/03/27 (TA) | 1997/04/22 | LEK PHARM | Discontinued |
ACYCLOVIR | 074658 | 002 | ANDA | ACYCLOVIR | TABLET;ORAL | 800MG | No | No | 1997/03/27 (TA) | 1997/04/22 | LEK PHARM | Discontinued |
ACYCLOVIR | 074556 | 001 | ANDA | ACYCLOVIR | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1997/04/22 | 1997/04/22 | TEVA | Discontinued |
ACYCLOVIR | 074556 | 002 | ANDA | ACYCLOVIR | TABLET;ORAL | 400MG | No | No | 1997/04/22 | 1997/04/22 | TEVA | Prescription |
ACYCLOVIR | 074556 | 003 | ANDA | ACYCLOVIR | TABLET;ORAL | 800MG | No | No | 1997/04/22 | 1997/04/22 | TEVA | Prescription |
ACYCLOVIR | 074578 | 001 | ANDA | ACYCLOVIR | CAPSULE;ORAL | 200MG | No | No | 1997/04/22 | 1997/04/22 | TEVA | Prescription |
ACYCLOVIR SODIUM | 074596 | 001 | ANDA | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No | 1997/04/22 | 1997/04/22 | CHARTWELL INJECTABLE | Discontinued |
ACYCLOVIR SODIUM | 074596 | 002 | ANDA | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 1997/04/22 | 1997/04/22 | CHARTWELL INJECTABLE | Discontinued |
ACYCLOVIR SODIUM | 074663 | 001 | ANDA | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 1997/04/22 | 1997/04/22 | HOSPIRA | Discontinued |
ACYCLOVIR SODIUM | 074663 | 002 | ANDA | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No | 1997/04/22 | 1997/04/22 | HOSPIRA | Discontinued |
ACYCLOVIR | 074674 | 001 | ANDA | ACYCLOVIR | CAPSULE;ORAL | 200MG | No | No | 1997/04/22 | 1997/04/22 | IVAX SUB TEVA PHARMS | Discontinued |
ACYCLOVIR SODIUM | 074720 | 001 | ANDA | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 25MG BASE/ML | No | No | 1997/04/22 | 1997/04/22 | HOSPIRA | Discontinued |
ACYCLOVIR | 074727 | 001 | ANDA | ACYCLOVIR | CAPSULE;ORAL | 200MG | No | No | 1997/04/22 | 1997/04/22 | AUROBINDO PHARMA USA | Discontinued |
ACYCLOVIR SODIUM | 074758 | 001 | ANDA | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 1997/04/22 | 1997/04/22 | HOSPIRA | Discontinued |
ACYCLOVIR SODIUM | 074758 | 002 | ANDA | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No | 1997/04/22 | 1997/04/22 | HOSPIRA | Discontinued |
ACYCLOVIR | 074828 | 001 | ANDA | ACYCLOVIR | CAPSULE;ORAL | 200MG | No | No | 1997/04/22 | 1997/04/22 | TEVA | Discontinued |
ACYCLOVIR | 074833 | 001 | ANDA | ACYCLOVIR | CAPSULE;ORAL | 200MG | No | No | 1997/04/22 | 1997/04/22 | STRIDES PHARMA | Discontinued |
ACYCLOVIR | 074836 | 001 | ANDA | ACYCLOVIR | TABLET;ORAL | 400MG | No | No | 1997/04/22 | 1997/04/22 | IVAX SUB TEVA PHARMS | Discontinued |