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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
IRINOTECAN HYDROCHLORIDE | 090675 | 001 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | No | No | 2011/12/16 | 2011/12/16 | HENGRUI PHARMA | Prescription |
IRINOTECAN HYDROCHLORIDE | 090675 | 002 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | No | No | 2011/12/16 | 2011/12/16 | HENGRUI PHARMA | Prescription |
IRINOTECAN HYDROCHLORIDE | 200771 | 001 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | No | No | 2012/02/14 | 2012/02/14 | EMCURE PHARMS LTD | Discontinued |
IRINOTECAN HYDROCHLORIDE | 200771 | 002 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | No | No | 2012/02/14 | 2012/02/14 | EMCURE PHARMS LTD | Discontinued |
IRINOTECAN HYDROCHLORIDE | 200771 | 003 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE; INJECTION | 100MG/5ML | No | No | 2012/02/14 | -- | EMCURE PHARMS LTD | Prescription |
IRINOTECAN HYDROCHLORIDE | 203380 | 001 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | No | No | 2016/05/03 | 2016/05/03 | QILU PHARM HAINAN | Prescription |
IRINOTECAN HYDROCHLORIDE | 203380 | 002 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | No | No | 2016/05/03 | 2016/05/03 | QILU PHARM HAINAN | Prescription |
IRINOTECAN HYDROCHLORIDE | 203380 | 003 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 300MG/15ML (20MG/ML) | No | No | 2016/05/03 | 2016/05/03 | QILU PHARM HAINAN | Prescription |
IRINOTECAN HYDROCHLORIDE | 206935 | 001 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | No | No | 2017/05/26 | 2017/05/26 | NOVAST LABS | Prescription |
IRINOTECAN HYDROCHLORIDE | 206935 | 002 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | No | No | 2017/05/26 | 2017/05/26 | NOVAST LABS | Prescription |
IRINOTECAN HYDROCHLORIDE | 203054 | 001 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | No | No | 2017/08/31 | 2017/08/31 | INTAS PHARMS USA | Prescription |
IRINOTECAN HYDROCHLORIDE | 203054 | 002 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | No | No | 2017/08/31 | 2017/08/31 | INTAS PHARMS USA | Prescription |
IRINOTECAN HYDROCHLORIDE | 208718 | 001 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | No | No | 2018/12/28 | 2018/12/28 | SHILPA | Prescription |
IRINOTECAN HYDROCHLORIDE | 208718 | 002 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | No | No | 2018/12/28 | 2018/12/28 | SHILPA | Prescription |
IRINOTECAN HYDROCHLORIDE | 208718 | 003 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 300MG/15ML (20MG/ML) | No | No | 2018/12/28 | 2019/08/16 | SHILPA | Prescription |
IRINOTECAN HYDROCHLORIDE | 212993 | 001 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | No | No | 2019/11/18 | 2019/11/18 | GLAND PHARMA LTD | Prescription |
IRINOTECAN HYDROCHLORIDE | 212993 | 002 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | No | No | 2019/11/18 | 2019/11/18 | GLAND PHARMA LTD | Prescription |
IRINOTECAN HYDROCHLORIDE | 213278 | 001 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | No | No | 2020/11/02 | 2020/11/02 | EUGIA PHARMA | Prescription |
IRINOTECAN HYDROCHLORIDE | 213278 | 002 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | No | No | 2020/11/02 | 2020/11/02 | EUGIA PHARMA | Prescription |
IRINOTECAN HYDROCHLORIDE | 213278 | 003 | ANDA | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 300MG/15ML (20MG/ML) | No | No | 2020/11/02 | 2020/11/02 | EUGIA PHARMA | Prescription |