药品注册申请号:018649
申请类型:NDA (新药申请)
申请人:BAXTER HLTHCARE
申请人全名:BAXTER HEALTHCARE 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 THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE INJECTABLE;INJECTION 40MG/100ML No No None 1982/07/26 1982/07/26 Discontinued
002 THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE INJECTABLE;INJECTION 80MG/100ML No No None 1982/07/26 Discontinued
003 THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE INJECTABLE;INJECTION 160MG/100ML No No None 1982/07/26 Discontinued
004 THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE INJECTABLE;INJECTION 200MG/100ML No No None 1982/07/26 Discontinued
005 THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE INJECTABLE;INJECTION 400MG/100ML No No None 1982/07/26 Discontinued
006 THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE INJECTABLE;INJECTION 320MG/100ML No No None 1985/11/13 Discontinued
007 THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE INJECTABLE;INJECTION 4MG/ML No No None 1982/07/26 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
2008/10/17 SUPPL-43(补充) Approval Labeling STANDARD
2003/12/31 SUPPL-40(补充) Approval Labeling STANDARD
1999/11/23 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
1999/07/16 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1997/12/22 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
1997/05/02 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1996/09/04 SUPPL-34(补充) Approval Labeling STANDARD
1994/09/26 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1994/07/27 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1994/02/25 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1993/05/27 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1992/11/03 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1992/10/16 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1989/01/12 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1987/11/18 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1986/04/15 SUPPL-5(补充) Approval Labeling
1986/02/27 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1985/11/13 SUPPL-10(补充) Approval Labeling
1985/11/13 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1985/09/14 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1985/06/13 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1985/04/26 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1985/04/10 SUPPL-11(补充) Approval Labeling
1984/10/04 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1984/04/30 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1984/04/30 SUPPL-3(补充) Approval Labeling
1984/02/28 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1982/09/02 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1982/07/26 ORIG-1(原始申请) Approval Type 4 - New Combination 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
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与本品治疗等效的药品
本品无治疗等效药品
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