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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
SODIUM BICARBONATE | 211091 | 001 | ANDA | SODIUM BICARBONATE | INJECTABLE;INJECTION | 0.5MEQ/ML | No | Yes | 2019/06/20 | 2019/06/20 | EXELA PHARMA | Prescription |
SODIUM BICARBONATE | 211091 | 002 | ANDA | SODIUM BICARBONATE | INJECTABLE;INJECTION | 0.9MEQ/ML | No | Yes | 2019/06/20 | 2019/06/20 | EXELA PHARMA | Prescription |
SODIUM BICARBONATE | 211091 | 003 | ANDA | SODIUM BICARBONATE | INJECTABLE;INJECTION | 1MEQ/ML | No | Yes | 2019/06/20 | 2019/06/20 | EXELA PHARMA | Prescription |
OMEPRAZOLE AND SODIUM BICARBONATE | 212587 | 001 | ANDA | OMEPRAZOLE; SODIUM BICARBONATE | CAPSULE;ORAL | 20MG;1.1GM | No | No | 2020/04/30 | 2020/04/30 | ANDA REPOSITORY | Prescription |
OMEPRAZOLE AND SODIUM BICARBONATE | 212587 | 002 | ANDA | OMEPRAZOLE; SODIUM BICARBONATE | CAPSULE;ORAL | 40MG;1.1GM | No | No | 2020/04/30 | 2020/04/30 | ANDA REPOSITORY | Prescription |
SODIUM BICARBONATE | 216364 | 001 | ANDA | SODIUM BICARBONATE | INJECTABLE;INJECTION | 1MEQ/ML | No | No | 2023/06/15 | 2023/06/15 | OMNIVIUM PHARMS | Prescription |
SODIUM BICARBONATE | 217594 | 001 | ANDA | SODIUM BICARBONATE | INJECTABLE;INJECTION | 1MEQ/ML | No | No | 2023/06/28 | 2023/06/28 | STERISCIENCE | Prescription |
SODIUM BICARBONATE | 216042 | 001 | ANDA | SODIUM BICARBONATE | INJECTABLE;INJECTION | 1MEQ/ML | No | No | 2024/02/27 | 2024/02/27 | LONG GROVE PHARMS | Prescription |
OMEPRAZOLE AND SODIUM BICARBONATE | 217784 | 001 | ANDA | OMEPRAZOLE; SODIUM BICARBONATE | FOR SUSPENSION;ORAL | 20MG/PACKET;1.68GM/PACKET | No | No | 2024/05/09 | 2024/05/09 | DR REDDYS | Over-the-counter |