药品注册申请号:018615
申请类型:NDA (新药申请)
申请人:PHARM ASSOC
申请人全名:PHARMACEUTICAL ASSOCIATES 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 SULFATRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML No No AB 1983/01/07 1983/01/07 Prescription
002 SULFATRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML No No None 1983/01/07 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
2021/10/15 SUPPL-80(补充) Approval Labeling STANDARD
2016/09/07 SUPPL-76(补充) Approval Manufacturing (CMC) UNKNOWN Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2003/09/25 SUPPL-56(补充) Approval Labeling
2001/02/07 SUPPL-53(补充) Approval Manufacturing (CMC)
2000/11/13 SUPPL-52(补充) Approval Manufacturing (CMC)
1997/10/21 SUPPL-51(补充) Approval Labeling
1997/06/20 SUPPL-48(补充) Approval Manufacturing (CMC)
1997/02/28 SUPPL-47(补充) Approval Manufacturing (CMC)
1997/01/07 SUPPL-50(补充) Approval Labeling
1997/01/07 SUPPL-46(补充) Approval Labeling
1997/01/07 SUPPL-44(补充) Approval Manufacturing (CMC)
1997/01/07 SUPPL-43(补充) Approval Manufacturing (CMC)
1997/01/07 SUPPL-41(补充) Approval Manufacturing (CMC)
1997/01/07 SUPPL-40(补充) Approval Manufacturing (CMC)
1995/11/08 SUPPL-39(补充) Approval Manufacturing (CMC)
1994/12/19 SUPPL-38(补充) Approval Labeling
1994/02/16 SUPPL-37(补充) Approval Labeling
1993/11/03 SUPPL-36(补充) Approval Manufacturing (CMC)
1993/11/03 SUPPL-35(补充) Approval Manufacturing (CMC)
1993/11/03 SUPPL-34(补充) Approval Manufacturing (CMC)
1993/11/03 SUPPL-33(补充) Approval Manufacturing (CMC)
1993/03/05 SUPPL-32(补充) Approval Bioequivalence
1993/01/22 SUPPL-29(补充) Approval Manufacturing (CMC)
1991/07/24 SUPPL-30(补充) Approval Manufacturing (CMC)
1991/02/26 SUPPL-22(补充) Approval Manufacturing (CMC)
1991/02/26 SUPPL-21(补充) Approval Manufacturing (CMC)
1990/09/28 SUPPL-31(补充) Approval Manufacturing (CMC)
1990/05/08 SUPPL-28(补充) Approval Labeling
1990/01/12 SUPPL-26(补充) Approval Labeling
1988/12/15 SUPPL-25(补充) Approval Manufacturing (CMC)
1988/12/15 SUPPL-24(补充) Approval Manufacturing (CMC)
1988/11/01 SUPPL-20(补充) Approval Labeling
1988/09/08 SUPPL-18(补充) Approval Manufacturing (CMC)
1988/07/14 SUPPL-19(补充) Approval Manufacturing (CMC)
1987/11/27 SUPPL-13(补充) Approval Manufacturing (CMC)
1987/04/22 SUPPL-12(补充) Approval Manufacturing (CMC)
1987/04/22 SUPPL-11(补充) Approval Manufacturing (CMC)
1986/02/13 SUPPL-9(补充) Approval Manufacturing (CMC)
1986/02/13 SUPPL-8(补充) Approval Manufacturing (CMC)
1986/02/13 SUPPL-7(补充) Approval Manufacturing (CMC)
1986/02/13 SUPPL-6(补充) Approval Manufacturing (CMC)
1983/01/07 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)
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:SULFAMETHOXAZOLE; TRIMETHOPRIM 剂型/给药途径:SUSPENSION;ORAL 规格:200MG/5ML;40MG/5ML 治疗等效代码:AB
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
018615 001 NDA SULFATRIM PEDIATRIC SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML Prescription No No AB 1983/01/07 PHARM ASSOC
074650 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML Prescription No Yes AB 1997/12/29 HIKMA
077612 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML Prescription No No AB 2006/11/13 PRASCO
077785 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML Prescription No No AB 2007/01/24 CHARTWELL MOLECULAR
091348 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML Prescription No No AB 2010/06/08 AUROBINDO PHARMA
214330 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML Prescription No No AB 2022/02/08 NOVITIUM PHARMA
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