药品注册申请号:016084
申请类型:NDA (新药申请)
申请人:CASPER PHARMA LLC
申请人全名:CASPER PHARMA LLC
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 ZYLOPRIM ALLOPURINOL TABLET;ORAL 100MG Yes No AB 1966/08/19 Approved Prior to Jan 1, 1982 Prescription
002 ZYLOPRIM ALLOPURINOL TABLET;ORAL 300MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
003 ZYLOPRIM ALLOPURINOL TABLET;ORAL 200MG Yes No AB 2022/08/04 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
2023/09/21 SUPPL-52(补充) Approval Labeling STANDARD
2023/09/21 SUPPL-51(补充) Approval Labeling STANDARD
2023/09/21 SUPPL-48(补充) Approval Labeling STANDARD
2022/08/04 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
2018/12/03 SUPPL-44(补充) Approval Labeling STANDARD
2002/07/17 SUPPL-41(补充) Approval Labeling STANDARD
1991/07/11 SUPPL-39(补充) Approval Manufacturing (CMC) PRIORITY
1989/05/16 SUPPL-29(补充) Approval Manufacturing (CMC) PRIORITY
1986/01/27 SUPPL-34(补充) Approval Manufacturing (CMC) PRIORITY
1985/06/07 SUPPL-38(补充) Approval Manufacturing (CMC) PRIORITY
1985/02/27 SUPPL-37(补充) Approval Manufacturing (CMC) PRIORITY
1985/02/25 SUPPL-30(补充) Approval Labeling
1983/06/01 SUPPL-36(补充) Approval Manufacturing (CMC) PRIORITY
1982/12/10 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
1982/12/08 SUPPL-35(补充) Approval Labeling
1982/06/10 SUPPL-33(补充) Approval Manufacturing (CMC) PRIORITY
1982/06/10 SUPPL-32(补充) Approval Manufacturing (CMC) PRIORITY
1980/02/01 SUPPL-27(补充) Approval Manufacturing (CMC) PRIORITY
1980/01/30 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
1977/04/06 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1976/12/06 SUPPL-21(补充) Approval Labeling
1976/01/16 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1966/08/19 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
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:ALLOPURINOL 剂型/给药途径:TABLET;ORAL 规格:100MG 治疗等效代码:AB
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
016084 001 NDA ZYLOPRIM ALLOPURINOL TABLET;ORAL 100MG Prescription Yes No AB Approved Prior to Jan 1, 1982 CASPER PHARMA LLC
018832 002 NDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 1984/09/28 WATSON LABS
018659 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 1986/10/24 MYLAN
071450 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 1987/01/09 SUN PHARM INDUSTRIES
071586 001 ANDA LOPURIN ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 1987/04/02 DR REDDYS LA
075798 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 2003/06/27 ENDO OPERATIONS
077353 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 2005/09/08 CHARTWELL
078253 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 2007/09/11 NORTHSTAR HLTHCARE
090637 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 2011/03/16 IPCA LABS LTD
203154 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 2013/05/06 ACCORD HLTHCARE
204467 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 2016/07/28 INDOCO
210117 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 2017/10/12 ZYDUS PHARMS
211820 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 2019/03/12 UNICHEM
214443 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 2022/03/07 HARMAN FINOCHEM
217748 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Prescription No No AB 2023/08/03 HETERO LABS LTD V
211807 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 100MG Discontinued No No AB 2023/12/14 LUPIN LTD
活性成分:ALLOPURINOL 剂型/给药途径:TABLET;ORAL 规格:300MG 治疗等效代码:AB
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
016084 002 NDA ZYLOPRIM ALLOPURINOL TABLET;ORAL 300MG Prescription Yes No AB Approved Prior to Jan 1, 1982 CASPER PHARMA LLC
018877 001 NDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 1984/09/28 WATSON LABS
018659 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 1986/10/24 MYLAN
071450 001 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 1987/01/09 SUN PHARM INDUSTRIES
071587 001 ANDA LOPURIN ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 1987/04/02 DR REDDYS LA
075798 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 2003/06/27 ENDO OPERATIONS
077353 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 2005/09/08 CHARTWELL
078253 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 2007/09/11 NORTHSTAR HLTHCARE
090637 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 2011/03/16 IPCA LABS LTD
203154 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 2013/05/06 ACCORD HLTHCARE
204467 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 2016/07/28 INDOCO
210117 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 2017/10/12 ZYDUS PHARMS
211820 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No Yes AB 2019/03/12 UNICHEM
214443 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 2022/03/07 HARMAN FINOCHEM
217748 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Prescription No No AB 2023/08/03 HETERO LABS LTD V
211807 002 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG Discontinued No No AB 2023/12/14 LUPIN LTD
活性成分:ALLOPURINOL 剂型/给药途径:TABLET;ORAL 规格:200MG 治疗等效代码:AB
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
016084 003 NDA ZYLOPRIM ALLOPURINOL TABLET;ORAL 200MG Prescription Yes No AB 2022/08/04 CASPER PHARMA LLC
214443 003 ANDA ALLOPURINOL ALLOPURINOL TABLET;ORAL 200MG Prescription No No AB 2024/06/17 HARMAN FINOCHEM
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