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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ARSENIC TRIOXIDE | 078729 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE; INJECTION | 10ML | No | No | 2008/10/03 (TA) | -- | TEVA PHARMS | None (Tentative Approval) |
ARSENIC TRIOXIDE | 208231 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 1MG/ML | No | Yes | 2018/08/31 | 2018/08/31 | FRESENIUS KABI USA | Prescription |
ARSENIC TRIOXIDE | 206228 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2018/11/13 | 2018/11/13 | ZYDUS PHARMS | Prescription |
ARSENIC TRIOXIDE | 206228 | 002 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 2MG/ML | No | No | 2018/11/13 | 2019/08/30 | ZYDUS PHARMS | Prescription |
ARSENIC TRIOXIDE | 210802 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2018/11/13 | 2018/11/13 | AMRING PHARMS | Prescription |
ARSENIC TRIOXIDE | 209315 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2018/11/15 | 2018/11/15 | INGENUS PHARMS LLC | Prescription |
ARSENIC TRIOXIDE | 209315 | 002 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 2MG/ML | No | No | 2018/11/15 | 2021/01/14 | INGENUS PHARMS LLC | Discontinued |
ARSENIC TRIOXIDE | 209780 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2018/11/15 | 2018/11/15 | NEXUS | Prescription |
ARSENIC TRIOXIDE | 209873 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2019/05/06 | 2019/05/06 | PENN LIFE | Prescription |
ARSENIC TRIOXIDE | 210739 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2021/01/25 | 2021/01/25 | AMNEAL | Prescription |
ARSENIC TRIOXIDE | 210739 | 002 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 2MG/ML | No | No | 2021/01/25 | 2021/08/19 | AMNEAL | Prescription |
ARSENIC TRIOXIDE | 215059 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 2MG/ML | No | No | 2021/10/07 | 2021/10/07 | GLAND PHARMA LTD | Prescription |
ARSENIC TRIOXIDE | 215059 | 002 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2021/10/07 | 2022/04/22 | GLAND PHARMA LTD | Prescription |
ARSENIC TRIOXIDE | 214011 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 2MG/ML | No | No | 2021/10/15 | 2021/10/15 | EUGIA PHARMA | Discontinued |
ARSENIC TRIOXIDE | 215359 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 2MG/ML | No | No | 2021/12/02 | 2021/12/02 | SANDOZ | Prescription |
ARSENIC TRIOXIDE | 217413 | 001 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 1MG/ML | No | No | 2023/04/20 | 2023/04/20 | ORBICULAR | Prescription |
ARSENIC TRIOXIDE | 217413 | 002 | ANDA | ARSENIC TRIOXIDE | INJECTABLE;INJECTION | 2MG/ML | No | No | 2023/04/20 | 2023/04/20 | ORBICULAR | Prescription |