药品注册申请号:008845
申请类型:NDA (新药申请)
申请人:HOSPIRA
申请人全名:HOSPIRA INC
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 QUELICIN PRESERVATIVE FREE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1953/05/01 Approved Prior to Jan 1, 1982 Discontinued
002 QUELICIN PRESERVATIVE FREE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 QUELICIN PRESERVATIVE FREE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
006 QUELICIN SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 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
2022/11/01 SUPPL-80(补充) Approval Labeling STANDARD
2022/02/17 SUPPL-79(补充) Approval Labeling STANDARD
2021/08/11 SUPPL-76(补充) Approval Labeling STANDARD
2018/07/26 SUPPL-73(补充) Approval Labeling STANDARD
2014/07/30 SUPPL-70(补充) Approval Manufacturing (CMC) STANDARD
2013/03/19 SUPPL-69(补充) Approval Manufacturing (CMC) STANDARD
2010/11/22 SUPPL-65(补充) Approval Labeling 901 REQUIRED
2002/12/17 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
2000/11/17 SUPPL-54(补充) Approval Manufacturing (CMC) STANDARD
2000/06/30 SUPPL-53(补充) Approval Labeling STANDARD
1999/01/29 SUPPL-52(补充) Approval Labeling STANDARD
1999/01/29 SUPPL-49(补充) Approval Labeling STANDARD
1998/05/26 SUPPL-50(补充) Approval Manufacturing (CMC) STANDARD
1997/10/27 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1994/11/28 SUPPL-47(补充) Approval Labeling STANDARD
1989/05/03 SUPPL-46(补充) Approval Labeling
1989/05/03 SUPPL-45(补充) Approval Manufacturing (CMC) STANDARD
1988/05/27 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1987/09/01 SUPPL-42(补充) Approval Labeling
1987/09/01 SUPPL-41(补充) Approval Labeling
1987/09/01 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1987/03/16 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
1984/06/27 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1982/05/05 SUPPL-34(补充) Approval Labeling
1982/03/16 SUPPL-28(补充) Approval Labeling
1981/11/10 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1981/10/23 SUPPL-33(补充) Approval Labeling
1981/08/06 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1981/05/16 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1981/02/10 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1980/12/03 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1980/09/03 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1980/09/03 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1980/09/03 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1979/12/11 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1978/08/22 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1978/04/18 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1977/09/06 SUPPL-19(补充) Approval Labeling
1977/09/06 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1977/06/20 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1976/12/14 SUPPL-17(补充) Approval Labeling
1976/12/14 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1976/12/14 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1976/07/20 SUPPL-15(补充) Approval Labeling
1976/06/22 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1976/05/06 SUPPL-13(补充) Approval Labeling
1976/05/06 SUPPL-12(补充) Approval Labeling
1953/05/01 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer STANDARD
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:SUCCINYLCHOLINE CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/ML 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
008453 002 NDA ANECTINE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 SANDOZ
008845 006 NDA QUELICIN SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
209467 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No Yes AP 2018/05/04 ZYDUS PHARMS
210231 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2018/06/04 AMRING PHARMS
211432 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2018/11/16 AMNEAL
210698 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2019/08/02 DR REDDYS
212638 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Discontinued No No AP 2019/10/09 BRECKENRIDGE
211589 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2020/01/15 SOMERSET THERAPS LLC
213810 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2020/05/04 ASPIRO
211625 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2020/05/19 NIVAGEN PHARMS INC
213705 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2020/05/20 ACCORD HLTHCARE
214308 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2020/05/22 INDOCO
213229 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2020/06/12 HIKMA
214246 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2020/06/16 GLAND PHARMA LTD
213552 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Discontinued No No AP 2020/10/27 NEXUS
211346 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2020/11/20 FRESENIUS KABI USA
214879 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2020/11/24 MICRO LABS
214491 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2020/12/21 DEVA HOLDING AS
215022 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2021/03/29 SAGENT PHARMS INC
214514 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2021/10/19 MEITHEAL
216003 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Prescription No No AP 2022/02/07 BE PHARMS
216127 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Discontinued No No AP 2023/02/02 MANKIND PHARMA
217808 001 ANDA SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML Discontinued No No AP 2023/10/16 EUGIA PHARMA
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