药品注册申请号:204890
申请类型:ANDA (仿制药申请)
申请人:QILU PHARM HAINAN
申请人全名:QILU PHARMACEUTICAL HAINAN CO LTD
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL No No AP 2022/05/25 2022/05/25 Prescription
002 PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL No No AP 2022/05/25 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2023/02/27 SUPPL-2(补充) Approval Labeling STANDARD
2022/05/25 ORIG-1(原始申请) Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:PEMETREXED DISODIUM 剂型/给药途径:POWDER;INTRAVENOUS 规格:EQ 100MG BASE/VIAL 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021462 002 NDA ALIMTA PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription Yes Yes AP 2007/09/07 LILLY
090384 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/05/25 FRESENIUS KABI USA
202111 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Discontinued No No AP 2022/05/25 HOSPIRA
202596 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/05/25 DR REDDYS
203485 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/05/25 ACCORD HLTHCARE
203774 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/05/25 APOTEX
204890 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/05/25 QILU PHARM HAINAN
207352 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/05/25 NANG KUANG PHARM CO
208696 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/05/25 JIANGSU HANSOH PHARM
211899 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/05/25 RELIANCE LIFE
214073 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/05/25 ZYDUS PHARMS
214632 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/05/25 EUGIA PHARMA
214436 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/08/18 BAXTER HLTHCARE CORP
215479 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2022/12/13 MEITHEAL
210047 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Discontinued No No AP 2023/05/08 AMNEAL
216582 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2023/12/11 PRINSTON INC
215460 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 100MG BASE/VIAL Prescription No No AP 2024/06/14 HETERO LABS LTD VI
活性成分:PEMETREXED DISODIUM 剂型/给药途径:POWDER;INTRAVENOUS 规格:EQ 500MG BASE/VIAL 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021462 001 NDA ALIMTA PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription Yes Yes AP 2004/02/04 LILLY
090384 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/05/25 FRESENIUS KABI USA
202111 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Discontinued No No AP 2022/05/25 HOSPIRA
202596 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/05/25 DR REDDYS
203485 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/05/25 ACCORD HLTHCARE
203774 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/05/25 APOTEX
204890 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/05/25 QILU PHARM HAINAN
207352 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/05/25 NANG KUANG PHARM CO
208696 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/05/25 JIANGSU HANSOH PHARM
211899 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/05/25 RELIANCE LIFE
214073 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/05/25 ZYDUS PHARMS
214632 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/05/25 EUGIA PHARMA
210047 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Discontinued No No AP 2022/08/04 AMNEAL
214436 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/08/18 BAXTER HLTHCARE CORP
215479 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2022/12/13 MEITHEAL
203628 001 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Discontinued No No AP 2023/03/10 MYLAN LABS LTD
215460 002 ANDA PEMETREXED DISODIUM PEMETREXED DISODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2024/06/14 HETERO LABS LTD VI
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