药品注册申请号:018877
申请类型:NDA (新药申请)
申请人:WATSON LABS
申请人全名:WATSON LABORATORIES 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 ALLOPURINOL ALLOPURINOL TABLET;ORAL 300MG No No AB 1984/09/28 1984/09/28 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
2015/11/13 SUPPL-62(补充) Approval Manufacturing (CMC)
2009/01/23 SUPPL-45(补充) Approval Labeling
2003/08/26 SUPPL-28(补充) Approval Labeling
2002/08/14 SUPPL-31(补充) Approval Manufacturing (CMC)
2001/04/25 SUPPL-30(补充) Approval Manufacturing (CMC)
2001/02/05 SUPPL-29(补充) Approval Manufacturing (CMC)
1998/03/30 SUPPL-26(补充) Approval Manufacturing (CMC)
1998/03/30 SUPPL-25(补充) Approval Manufacturing (CMC)
1993/07/30 SUPPL-21(补充) Approval Manufacturing (CMC)
1991/05/31 SUPPL-19(补充) Approval Manufacturing (CMC)
1991/01/28 SUPPL-20(补充) Approval Manufacturing (CMC)
1990/06/29 SUPPL-18(补充) Approval Manufacturing (CMC)
1988/07/07 SUPPL-17(补充) Approval Manufacturing (CMC)
1988/07/07 SUPPL-16(补充) Approval Manufacturing (CMC)
1987/12/17 SUPPL-15(补充) Approval Manufacturing (CMC)
1987/12/17 SUPPL-14(补充) Approval Manufacturing (CMC)
1987/12/17 SUPPL-13(补充) Approval Manufacturing (CMC)
1987/03/11 SUPPL-11(补充) Approval Manufacturing (CMC)
1985/07/03 SUPPL-7(补充) Approval Manufacturing (CMC)
1985/07/03 SUPPL-6(补充) Approval Manufacturing (CMC)
1985/07/03 SUPPL-2(补充) Approval Manufacturing (CMC)
1985/05/10 SUPPL-4(补充) Approval Manufacturing (CMC)
1985/05/10 SUPPL-3(补充) Approval Manufacturing (CMC)
1984/09/28 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: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 VINTAGE PHARMS
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 Prescription No No AB 2023/12/14 LUPIN LTD
更多信息
药品NDC数据与药品包装、标签说明书
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