药品注册申请号：012462
申请类型：NDA (新药申请)
申请人：PFIZER
申请人全名：PFIZER 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 LOMOTIL ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Yes Yes AA 1960/09/15 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1960/09/15 ORIG-1（原始申请） Approval Type 4 - New Combination PRIORITY
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2018/02/12 SUPPL-48（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2017/10/05 SUPPL-45（补充） Approval Labeling-Package Insert STANDARD
2006/04/28 SUPPL-42（补充） Approval Labeling STANDARD
1996/06/07 SUPPL-41（补充） Approval Manufacturing (CMC) PRIORITY
1994/02/18 SUPPL-40（补充） Approval Labeling STANDARD
1991/04/23 SUPPL-39（补充） Approval Labeling
1987/03/12 SUPPL-38（补充） Approval Labeling
1986/06/04 SUPPL-37（补充） Approval Manufacturing (CMC) PRIORITY
1986/04/07 SUPPL-36（补充） Approval Labeling
1984/03/01 SUPPL-35（补充） Approval Labeling
1983/12/21 SUPPL-34（补充） Approval Labeling
1983/04/07 SUPPL-33（补充） Approval Manufacturing (CMC)-Control PRIORITY
1982/03/04 SUPPL-31（补充） Approval Labeling
1981/01/08 SUPPL-29（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1980/12/30 SUPPL-30（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1979/11/05 SUPPL-27（补充） Approval Labeling
1979/02/22 SUPPL-28（补充） Approval Labeling
1977/02/28 SUPPL-26（补充） Approval Labeling
1977/02/28 SUPPL-25（补充） Approval Manufacturing (CMC)-Packaging 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
无
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
无
与本品治疗等效的药品
>>>活性成分:ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:0.025MG;2.5MG; 治疗等效代码:AA<<<
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
012462 001 NDA LOMOTIL ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Prescription Yes Yes AA Approved Prior to Jan 1, 1982 PFIZER
085372 001 ANDA DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Prescription No No AA Approved Prior to Jan 1, 1982 LANNETT
085762 001 ANDA DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Discontinued No No AA Approved Prior to Jan 1, 1982 PHARMOBEDIENT
086727 001 ANDA DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Prescription No No AA Approved Prior to Jan 1, 1982 ANI PHARMS
210571 001 ANDA DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Discontinued No No AA 2018/08/31 UPSHER SMITH LABS
210819 001 ANDA DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Prescription No No AA 2018/11/13 UNICHEM
213413 001 ANDA DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Prescription No No AA 2020/02/20 LEADING
213335 001 ANDA DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Prescription No No AA 2020/10/06 SPECGX LLC
207128 001 ANDA DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Prescription No No AA 2020/10/21 CHARTWELL RX
211362 001 ANDA DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG Prescription No No AA 2021/01/27 WINDER LABS LLC
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