药品注册申请号:050278
申请类型:NDA (新药申请)
申请人:AVET
申请人全名:AVET PHARMACEUTICALS 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 ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 500MG Yes No AB 1957/10/08 Approved Prior to Jan 1, 1982 Discontinued
003 ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 250MG Yes No AB 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
2016/07/21 SUPPL-39(补充) Approval Manufacturing (CMC)
2016/05/19 SUPPL-40(补充) Approval Manufacturing (CMC)
2015/04/27 SUPPL-37(补充) Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2015/04/21 SUPPL-36(补充) Approval Manufacturing (CMC)
1999/03/17 SUPPL-33(补充) Approval Manufacturing (CMC)
1992/05/15 SUPPL-17(补充) Approval Manufacturing (CMC)
1991/11/15 SUPPL-12(补充) Approval Labeling
1990/03/20 SUPPL-15(补充) Approval Manufacturing (CMC)
1961/10/26 SUPPL-32(补充) Approval Labeling
1961/03/16 SUPPL-31(补充) Approval Labeling
1961/01/16 SUPPL-30(补充) Approval Manufacturing (CMC)
1960/12/20 SUPPL-28(补充) Approval Manufacturing (CMC)
1960/12/02 SUPPL-27(补充) Approval Manufacturing (CMC)
1959/09/22 SUPPL-26(补充) Approval Manufacturing (CMC)
1959/02/13 SUPPL-25(补充) Approval Manufacturing (CMC)
1958/10/01 SUPPL-24(补充) Approval Manufacturing (CMC)
1958/09/15 SUPPL-23(补充) Approval Labeling
1958/09/15 SUPPL-22(补充) Approval Labeling
1958/05/28 SUPPL-21(补充) Approval Labeling
1958/04/25 SUPPL-20(补充) Approval Manufacturing (CMC)
1957/10/08 ORIG-1(原始申请) Approval UNKNOWN
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:TETRACYCLINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:500MG 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
050278 001 NDA ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 500MG Discontinued Yes No AB Approved Prior to Jan 1, 1982 AVET
061837 002 ANDA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 500MG Prescription No No AB Approved Prior to Jan 1, 1982 WATSON LABS
062752 002 ANDA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 500MG Prescription No No AB 1988/08/12 CHARTWELL TETRA
210674 002 ANDA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 500MG Prescription No Yes AB 2018/09/18 AMNEAL PHARMS NY
210662 002 ANDA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 500MG Prescription No No AB 2018/11/07 BRECKENRIDGE
212635 002 ANDA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 500MG Prescription No No AB 2020/03/03 STRIDES PHARMA
活性成分:TETRACYCLINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:250MG 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
050278 003 NDA ACHROMYCIN V TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 250MG Discontinued Yes No AB Approved Prior to Jan 1, 1982 AVET
061837 001 ANDA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB Approved Prior to Jan 1, 1982 WATSON LABS
062752 001 ANDA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 1988/08/12 CHARTWELL TETRA
210674 001 ANDA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2018/09/18 AMNEAL PHARMS NY
210662 001 ANDA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2018/11/07 BRECKENRIDGE
212635 001 ANDA TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL 250MG Prescription No No AB 2020/03/03 STRIDES PHARMA
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