美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=VARENICLINE"
符合检索条件的记录共 34 条
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商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
VARENICLINE 201920 001 ANDA VARENICLINE TABLET; ORAL 0.5MG No No 2013/09/10 (TA) -- TEVA PHARMS USA None (Tentative Approval)
VARENICLINE 201920 002 ANDA VARENICLINE TABLET; ORAL 1MG No No 2013/09/10 (TA) -- TEVA PHARMS USA None (Tentative Approval)
VARENICLINE TARTRATE 201808 001 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 0.5MG BASE No No 2016/12/15 (TA) -- WATSON LABS INC None (Tentative Approval)
VARENICLINE TARTRATE 201808 002 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 1MG BASE No No 2016/12/15 (TA) -- WATSON LABS INC None (Tentative Approval)
VARENICLINE TARTRATE 201785 001 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 0.5MG BASE No No 2021/08/11 2021/08/11 ENDO OPERATIONS Prescription
VARENICLINE TARTRATE 201785 002 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 1MG BASE No Yes 2021/08/11 2021/08/11 ENDO OPERATIONS Prescription
VARENICLINE TARTRATE 201962 001 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 0.5MG BASE No No 2023/01/25 2023/01/25 APOTEX Prescription
VARENICLINE TARTRATE 201962 002 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 1MG BASE No No 2023/01/25 2023/01/25 APOTEX Prescription
VARENICLINE TARTRATE 216723 001 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 0.5MG BASE No No 2023/06/12 2023/06/12 ZYDUS Prescription
VARENICLINE TARTRATE 216723 002 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 1MG BASE No No 2023/06/12 2023/06/12 ZYDUS Prescription
VARENICLINE TARTRATE 217151 001 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 0.5MG BASE No No 2023/07/25 2023/07/25 MEDLEY PHARMS Prescription
VARENICLINE TARTRATE 217151 002 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 1MG BASE No No 2023/07/25 2023/07/25 MEDLEY PHARMS Prescription
VARENICLINE TARTRATE 214255 001 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 0.5MG BASE No No 2023/08/01 2023/08/01 MANKIND PHARMA Prescription
VARENICLINE TARTRATE 214255 002 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 1MG BASE No No 2023/08/01 2023/08/01 MANKIND PHARMA Prescription
VARENICLINE TARTRATE 214557 001 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 0.5MG BASE No No 2023/08/23 2023/08/23 ALKEM LABS LTD Prescription
VARENICLINE TARTRATE 214557 002 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 1MG BASE No No 2023/08/23 2023/08/23 ALKEM LABS LTD Prescription
VARENICLINE TARTRATE 214571 001 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 0.5MG BASE No No 2023/10/23 2023/10/23 HETERO LABS LTD III Prescription
VARENICLINE TARTRATE 214571 002 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 1MG BASE No No 2023/10/23 2023/10/23 HETERO LABS LTD III Prescription
VARENICLINE TARTRATE 211862 001 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 0.5MG BASE No No 2023/12/04 2023/12/04 LUPIN LTD Prescription
VARENICLINE TARTRATE 211862 002 ANDA VARENICLINE TARTRATE TABLET;ORAL EQ 1MG BASE No No 2023/12/04 2023/12/04 LUPIN LTD Prescription
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