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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
NICOTINE POLACRILEX | 212057 | 001 | ANDA | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 2MG BASE | No | No | 2020/05/14 | 2020/05/14 | P AND L | Over-the-counter |
NICOTINE POLACRILEX | 212057 | 002 | ANDA | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 4MG BASE | No | No | 2020/05/14 | 2020/05/14 | P AND L | Over-the-counter |
NICOTINE POLACRILEX | 213233 | 001 | ANDA | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 2MG BASE | No | No | 2020/08/04 | 2020/08/04 | DR REDDYS LABS SA | Over-the-counter |
NICOTINE POLACRILEX | 213233 | 002 | ANDA | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 4MG BASE | No | No | 2020/08/04 | 2020/08/04 | DR REDDYS LABS SA | Over-the-counter |
NICOTINE POLACRILEX | 213266 | 001 | ANDA | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 2MG BASE | No | No | 2021/08/03 | 2021/08/03 | AUROBINDO PHARMA | Over-the-counter |
NICOTINE POLACRILEX | 213266 | 002 | ANDA | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 4MG BASE | No | No | 2021/08/03 | 2021/08/03 | AUROBINDO PHARMA | Over-the-counter |
NICOTINE POLACRILEX | 215357 | 001 | ANDA | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 2MG BASE | No | No | 2022/05/13 | 2022/05/13 | AUROBINDO PHARMA LTD | Over-the-counter |
NICOTINE POLACRILEX | 215357 | 002 | ANDA | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 4MG BASE | No | No | 2022/05/13 | 2022/05/13 | AUROBINDO PHARMA LTD | Over-the-counter |
NICOTINE POLACRILEX | 214354 | 001 | ANDA | NICOTINE POLACRILEX | GUM, CHEWING;BUCCAL | EQ 4MG BASE | No | No | 2022/12/21 | 2022/12/21 | FERTIN PHARMA | Discontinued |