BACTRIM-美国FDA药品数据库-药物在线

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	BACTRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	SUSPENSION;ORAL	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1975/04/15	Approved Prior to Jan 1, 1982	Discontinued
002	BACTRIM PEDIATRIC	SULFAMETHOXAZOLE; TRIMETHOPRIM	SUSPENSION;ORAL	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	None	1975/04/15	Approved Prior to Jan 1, 1982	Discontinued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

>>>原始批准或临时批准<<<

审批日期	提交号	审批结论	提交分类	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
1975/04/15	ORIG-1（原始申请）	Approval	Type 3 - New Dosage Form	STANDARD

>>>补充申请<<<

审批日期	提交号	审批结论	补充类别或审批类型	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
2025/02/21	SUPPL-47（补充）	Approval	Labeling-Package Insert	STANDARD	Label Letter
2024/06/24	SUPPL-46（补充）	Approval	Labeling-Package Insert	STANDARD	Letter Label
2021/05/21	SUPPL-45（补充）	Approval	Labeling-Package Insert	STANDARD	Label Letter
2020/07/28	SUPPL-44（补充）	Approval	Labeling-Package Insert	STANDARD	Letter Label
2001/11/09	SUPPL-43（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1996/03/06	SUPPL-35（补充）	Approval	Labeling
1990/06/15	SUPPL-39（补充）	Approval	Efficacy-New Indication			Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
1987/08/11	SUPPL-34（补充）	Approval	Labeling
1987/06/04	SUPPL-36（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/06/10	SUPPL-33（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/02/20	SUPPL-32（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/11/23	SUPPL-30（补充）	Approval	Labeling
1984/06/12	SUPPL-31（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/06/15	SUPPL-28（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/03/29	SUPPL-27（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1982/02/23	SUPPL-18（补充）	Approval	Efficacy
1981/10/09	SUPPL-26（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/04/23	SUPPL-25（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/01/09	SUPPL-24（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/01/09	SUPPL-23（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/01/09	SUPPL-22（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/12/10	SUPPL-20（补充）	Approval	Manufacturing (CMC)-Expiration Date	STANDARD
1980/10/31	SUPPL-19（补充）	Approval	Labeling
1980/10/28	SUPPL-21（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1979/12/17	SUPPL-17（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1979/12/17	SUPPL-16（补充）	Approval	Labeling
1979/12/17	SUPPL-14（补充）	Approval	Labeling
1979/12/07	SUPPL-15（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1979/12/07	SUPPL-13（补充）	Approval	Manufacturing (CMC)	STANDARD
1979/07/26	SUPPL-12（补充）	Approval	Labeling
1979/02/27	SUPPL-11（补充）	Approval	Manufacturing (CMC)-Formulation	STANDARD
1978/10/11	SUPPL-8（补充）	Approval	Labeling
1978/03/01	SUPPL-7（补充）	Approval	Labeling
1977/11/14	SUPPL-10（补充）	Approval	Labeling
1977/04/21	SUPPL-9（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1976/12/27	SUPPL-5（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1976/08/23	SUPPL-6（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1976/06/01	SUPPL-3（补充）	Approval	Labeling