美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=BAL"
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
PREGABALIN 213313 001 ANDA PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG No No 2021/04/13 2021/04/13 APOTEX Prescription
PREGABALIN 213313 002 ANDA PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG No No 2021/04/13 2021/04/13 APOTEX Prescription
LYBALVI 213378 001 NDA OLANZAPINE; SAMIDORPHAN L-MALATE TABLET;ORAL 5MG;EQ 10MG BASE Yes Yes 2021/05/28 2021/05/28 ALKERMES INC Prescription
LYBALVI 213378 001 NDA OLANZAPINE; SAMIDORPHAN L-MALATE TABLET;ORAL 5MG;EQ 10MG BASE Yes Yes 2021/05/28 2021/05/28 ALKERMES INC Prescription
LYBALVI 213378 002 NDA OLANZAPINE; SAMIDORPHAN L-MALATE TABLET;ORAL 10MG;EQ 10MG BASE Yes No 2021/05/28 2021/05/28 ALKERMES INC Prescription
LYBALVI 213378 002 NDA OLANZAPINE; SAMIDORPHAN L-MALATE TABLET;ORAL 10MG;EQ 10MG BASE Yes No 2021/05/28 2021/05/28 ALKERMES INC Prescription
LYBALVI 213378 003 NDA OLANZAPINE; SAMIDORPHAN L-MALATE TABLET;ORAL 15MG;EQ 10MG BASE Yes No 2021/05/28 2021/05/28 ALKERMES INC Prescription
LYBALVI 213378 003 NDA OLANZAPINE; SAMIDORPHAN L-MALATE TABLET;ORAL 15MG;EQ 10MG BASE Yes No 2021/05/28 2021/05/28 ALKERMES INC Prescription
LYBALVI 213378 004 NDA OLANZAPINE; SAMIDORPHAN L-MALATE TABLET;ORAL 20MG;EQ 10MG BASE Yes No 2021/05/28 2021/05/28 ALKERMES INC Prescription
LYBALVI 213378 004 NDA OLANZAPINE; SAMIDORPHAN L-MALATE TABLET;ORAL 20MG;EQ 10MG BASE Yes No 2021/05/28 2021/05/28 ALKERMES INC Prescription
PREGABALIN 211431 001 ANDA PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG No No 2021/07/02 2021/07/02 MYLAN Discontinued
PREGABALIN 211687 001 ANDA PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG No No 2021/07/06 2021/07/06 ALVOGEN Discontinued
PREGABALIN 211687 002 ANDA PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG No No 2021/07/06 2021/07/06 ALVOGEN Discontinued
PREGABALIN 211687 003 ANDA PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG No No 2021/07/06 2021/07/06 ALVOGEN Discontinued
PREGABALIN 211685 001 ANDA PREGABALIN CAPSULE;ORAL 25MG No No 2021/07/07 2021/07/07 APOTEX Prescription
PREGABALIN 211685 002 ANDA PREGABALIN CAPSULE;ORAL 50MG No No 2021/07/07 2021/07/07 APOTEX Prescription
PREGABALIN 211685 003 ANDA PREGABALIN CAPSULE;ORAL 75MG No No 2021/07/07 2021/07/07 APOTEX Prescription
PREGABALIN 211685 004 ANDA PREGABALIN CAPSULE;ORAL 100MG No No 2021/07/07 2021/07/07 APOTEX Prescription
PREGABALIN 211685 005 ANDA PREGABALIN CAPSULE;ORAL 150MG No No 2021/07/07 2021/07/07 APOTEX Prescription
PREGABALIN 211685 006 ANDA PREGABALIN CAPSULE;ORAL 200MG No No 2021/07/07 2021/07/07 APOTEX Prescription
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