药品注册申请号:019141
申请类型:NDA (新药申请)
申请人:FOUGERA PHARMS INC
申请人全名:FOUGERA PHARMACEUTICALS 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 BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE OINTMENT;TOPICAL EQ 0.05% BASE Yes Yes AB 1984/09/04 1984/09/04 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
1996/06/07 SUPPL-12(补充) Approval Manufacturing (CMC)
1996/03/07 SUPPL-14(补充) Approval Manufacturing (CMC)
1995/08/17 SUPPL-13(补充) Approval Labeling
1992/07/16 SUPPL-11(补充) Approval Manufacturing (CMC)
1988/11/01 SUPPL-10(补充) Approval Manufacturing (CMC)
1988/11/01 SUPPL-9(补充) Approval Manufacturing (CMC)
1988/11/01 SUPPL-8(补充) Approval Manufacturing (CMC)
1987/10/20 SUPPL-5(补充) Approval Manufacturing (CMC)
1987/07/06 SUPPL-6(补充) Approval Manufacturing (CMC)
1987/04/23 SUPPL-7(补充) Approval Manufacturing (CMC)
1986/06/27 SUPPL-2(补充) Approval Manufacturing (CMC)
1986/03/28 SUPPL-1(补充) Approval Manufacturing (CMC)
1984/09/04 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:BETAMETHASONE DIPROPIONATE 剂型/给药途径:OINTMENT;TOPICAL 规格:EQ 0.05% BASE 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
019141 001 NDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE OINTMENT;TOPICAL EQ 0.05% BASE Prescription Yes Yes AB 1984/09/04 FOUGERA PHARMS INC
071012 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE OINTMENT;TOPICAL EQ 0.05% BASE Prescription No No AB 1987/02/03 ACTAVIS MID ATLANTIC
074271 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE OINTMENT;TOPICAL EQ 0.05% BASE Prescription No No AB 1994/09/15 TARO
214048 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE OINTMENT;TOPICAL EQ 0.05% BASE Prescription No No AB 2020/07/14 ZYDUS LIFESCIENCES
215186 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE OINTMENT;TOPICAL EQ 0.05% BASE Prescription No No AB 2022/02/18 TASMAN PHARMA
215847 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE OINTMENT;TOPICAL EQ 0.05% BASE Prescription No No AB 2022/04/12 PADAGIS ISRAEL
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