药品注册申请号:074307
申请类型:ANDA (仿制药申请)
申请人:BAUSCH AND LOMB
申请人全名:BAUSCH AND LOMB 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 LEVOBUNOLOL HYDROCHLORIDE LEVOBUNOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.25% No No None 1994/03/04 1994/03/04 Discontinued
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
2002/12/19 SUPPL-19(补充) Approval Labeling
2001/11/27 SUPPL-18(补充) Approval Manufacturing (CMC)
2001/03/07 SUPPL-17(补充) Approval Manufacturing (CMC)
2000/10/05 SUPPL-16(补充) Approval Manufacturing (CMC)
2000/06/27 SUPPL-15(补充) Approval Manufacturing (CMC)
2000/05/18 SUPPL-12(补充) Approval Manufacturing (CMC)
2000/05/15 SUPPL-14(补充) Approval Manufacturing (CMC)
2000/04/28 SUPPL-13(补充) Approval Manufacturing (CMC)
1999/06/07 SUPPL-11(补充) Approval Manufacturing (CMC)
1998/11/19 SUPPL-9(补充) Approval Manufacturing (CMC)
1998/09/08 SUPPL-10(补充) Approval Manufacturing (CMC)
1998/03/11 SUPPL-7(补充) Approval Manufacturing (CMC)
1998/01/28 SUPPL-8(补充) Approval Manufacturing (CMC)
1996/05/30 SUPPL-5(补充) Approval Manufacturing (CMC)
1996/05/28 SUPPL-6(补充) Approval Manufacturing (CMC)
1995/11/20 SUPPL-4(补充) Approval Manufacturing (CMC)
1995/11/20 SUPPL-2(补充) Approval Manufacturing (CMC)
1994/05/23 SUPPL-1(补充) Approval Manufacturing (CMC)
1994/03/04 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)
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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
本品无治疗等效药品
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