药品注册申请号:011963
申请类型:NDA (新药申请)
申请人:FERA PHARMS LLC
申请人全名:FERA PHARMACEUTICALS LLC
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 PHOSPHOLINE IODIDE ECHOTHIOPHATE IODIDE FOR SOLUTION;OPHTHALMIC 0.125% Yes Yes None 1960/06/27 Approved Prior to Jan 1, 1982 Prescription
002 PHOSPHOLINE IODIDE ECHOTHIOPHATE IODIDE FOR SOLUTION;OPHTHALMIC 0.03% No No None Approved Prior to Jan 1, 1982 Discontinued
003 PHOSPHOLINE IODIDE ECHOTHIOPHATE IODIDE FOR SOLUTION;OPHTHALMIC 0.25% No No None Approved Prior to Jan 1, 1982 Discontinued
004 PHOSPHOLINE IODIDE ECHOTHIOPHATE IODIDE FOR SOLUTION;OPHTHALMIC 0.06% No No None Approved Prior to Jan 1, 1982 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
2021/10/28 SUPPL-52(补充) Approval Labeling STANDARD
2018/07/03 SUPPL-48(补充) Approval Labeling STANDARD
2014/02/28 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
2006/03/09 SUPPL-34(补充) Approval Labeling STANDARD
2002/04/12 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1998/03/10 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1995/03/21 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1993/05/17 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1990/07/13 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1990/01/09 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1989/08/01 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1988/11/29 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1987/05/11 SUPPL-23(补充) Approval Labeling
1984/10/30 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1982/06/10 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1982/05/26 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1981/12/28 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1981/11/25 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1981/05/19 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1980/01/02 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1979/08/01 SUPPL-17(补充) Approval Labeling
1978/08/09 SUPPL-15(补充) Approval Labeling
1978/08/09 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1978/08/09 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1976/10/13 SUPPL-12(补充) Approval Supplement STANDARD
1960/06/27 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity STANDARD
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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