药品注册申请号:050268
申请类型:NDA (新药申请)
申请人:STORZ
申请人全名:STORZ OPHTHALMICS INC SUB AMERICAN CYANAMID CO
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 ACHROMYCIN TETRACYCLINE HYDROCHLORIDE SUSPENSION/DROPS;OPHTHALMIC 1% No No None 1955/11/23 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
1991/06/28 SUPPL-11(补充) Approval Manufacturing (CMC)
1988/12/01 SUPPL-30(补充) Approval Manufacturing (CMC)
1986/06/27 SUPPL-8(补充) Approval Labeling
1986/05/23 SUPPL-6(补充) Approval Manufacturing (CMC)
1985/09/13 SUPPL-5(补充) Approval Manufacturing (CMC)
1983/06/21 SUPPL-4(补充) Approval Manufacturing (CMC)
1983/06/21 SUPPL-3(补充) Approval Manufacturing (CMC)
1983/03/22 SUPPL-2(补充) Approval Manufacturing (CMC)
1982/12/09 SUPPL-1(补充) Approval Manufacturing (CMC)
1982/03/23 SUPPL-29(补充) Approval Manufacturing (CMC)
1981/07/24 SUPPL-28(补充) Approval Labeling
1981/03/20 SUPPL-27(补充) Approval Manufacturing (CMC)
1975/12/29 SUPPL-26(补充) Approval Labeling
1975/10/06 SUPPL-25(补充) Approval Manufacturing (CMC)
1975/06/13 SUPPL-23(补充) Approval Manufacturing (CMC)
1975/04/25 SUPPL-24(补充) Approval Manufacturing (CMC)
1974/08/28 SUPPL-22(补充) Approval Manufacturing (CMC)
1974/05/06 SUPPL-21(补充) Approval Manufacturing (CMC)
1974/01/09 SUPPL-20(补充) Approval Manufacturing (CMC)
1972/07/28 SUPPL-19(补充) Approval Labeling
1970/06/12 SUPPL-18(补充) Approval Manufacturing (CMC)
1968/11/05 SUPPL-17(补充) Approval Manufacturing (CMC)
1965/10/20 SUPPL-16(补充) Approval Manufacturing (CMC)
1965/03/25 SUPPL-15(补充) Approval Manufacturing (CMC)
1963/05/01 SUPPL-14(补充) Approval Labeling
1962/02/20 SUPPL-13(补充) Approval Labeling
1962/02/20 SUPPL-9(补充) Approval Manufacturing (CMC)
1961/10/30 SUPPL-10(补充) Approval Labeling
1961/03/17 SUPPL-7(补充) Approval Labeling
1955/11/23 ORIG-1(原始申请) Approval UNKNOWN
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