药品注册申请号:050541
申请类型:NDA (新药申请)
申请人:NOVARTIS
申请人全名:NOVARTIS PHARMACEUTICALS CORP
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 TOBREX TOBRAMYCIN SOLUTION/DROPS;OPHTHALMIC 0.3% Yes Yes AT 1980/12/12 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
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
2021/05/14 SUPPL-31(补充) Approval Labeling STANDARD
2020/04/24 SUPPL-30(补充) Approval Labeling STANDARD
2012/12/18 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
2012/12/14 SUPPL-24(补充) Approval Labeling STANDARD
2003/07/22 SUPPL-17(补充) Approval Labeling STANDARD
2002/12/04 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2002/05/02 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
2000/02/18 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1999/08/17 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1999/03/11 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1999/02/05 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1998/12/18 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1998/08/04 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1998/01/15 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1996/06/25 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1996/03/05 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1995/11/01 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1995/11/01 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1995/06/13 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1994/07/27 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1994/06/13 SUPPL-2(补充) Approval Labeling STANDARD
1980/12/12 ORIG-1(原始申请) Approval Type 3 - New Dosage Form STANDARD
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:TOBRAMYCIN 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:0.3% 治疗等效代码:AT
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
050541 001 NDA TOBREX TOBRAMYCIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 NOVARTIS
062535 001 ANDA TOBREX TOBRAMYCIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 1984/12/13 SANDOZ
064052 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 1993/11/29 BAUSCH AND LOMB
064096 001 ANDA AKTOB TOBRAMYCIN SOLUTION/DROPS;OPHTHALMIC 0.3% Discontinued No No AT 1996/01/31 EPIC PHARMA LLC
065026 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2001/09/11 CHARTWELL RX
207444 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2017/06/28 SOMERSET THERAPS LLC
211847 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2019/04/19 ALEMBIC
212628 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2021/03/09 GLAND PHARMA LTD
更多信息
药品NDC数据与药品包装、标签说明书
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