| 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 | 是否参比药物 |
是否生物等效参考标准 |
治疗等效代码 | 产品批准日期 | 申请人 | 市场状态 |
专利及市场独占权 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BENDOPA | 016948 | 002 | NDA | LEVODOPA | CAPSULE;ORAL | 500MG | No | No | Approved Prior to Jan 1, 1982 | VALEANT PHARM INTL | DISCN | 详细信息 | |
| BENTYL | 007409 | 003 | NDA | DICYCLOMINE HYDROCHLORIDE | CAPSULE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1984/10/15 | ALLERGAN | DISCN | 详细信息 | |
| BENZONATATE | 091310 | 001 | ANDA | BENZONATATE | CAPSULE;ORAL | 100MG | No | No | 2015/01/16 | ACELLA | DISCN | 详细信息 | |
| BENZONATATE | 091310 | 002 | ANDA | BENZONATATE | CAPSULE;ORAL | 200MG | No | No | 2015/01/16 | ACELLA | DISCN | 详细信息 | |
| BENZONATATE | 211518 | 001 | ANDA | BENZONATATE | CAPSULE;ORAL | 100MG | No | No | AA | 2019/02/22 | ASCENT PHARMS INC | RX | 详细信息 |
| BENZONATATE | 211518 | 002 | ANDA | BENZONATATE | CAPSULE;ORAL | 150MG | No | No | 2019/02/22 | ASCENT PHARMS INC | DISCN | 详细信息 | |
| BENZONATATE | 211518 | 003 | ANDA | BENZONATATE | CAPSULE;ORAL | 200MG | No | No | AA | 2019/02/22 | ASCENT PHARMS INC | RX | 详细信息 |
| BENZONATATE | 081297 | 001 | ANDA | BENZONATATE | CAPSULE;ORAL | 100MG | No | No | AA | 1993/01/29 | BIONPHARMA | RX | 详细信息 |
| BENZONATATE | 081297 | 002 | ANDA | BENZONATATE | CAPSULE;ORAL | 200MG | No | No | AA | 2007/10/30 | BIONPHARMA | RX | 详细信息 |
| BENZONATATE | 210562 | 001 | ANDA | BENZONATATE | CAPSULE;ORAL | 100MG | No | No | 2018/11/09 | CHARTWELL RX | DISCN | 详细信息 | |
| BENZONATATE | 210562 | 002 | ANDA | BENZONATATE | CAPSULE;ORAL | 150MG | No | No | 2018/11/09 | CHARTWELL RX | DISCN | 详细信息 | |
| BENZONATATE | 210562 | 003 | ANDA | BENZONATATE | CAPSULE;ORAL | 200MG | No | No | 2018/11/09 | CHARTWELL RX | DISCN | 详细信息 | |
| BENZONATATE | 202765 | 002 | ANDA | BENZONATATE | CAPSULE;ORAL | 100MG | No | No | AA | 2017/08/25 | CSPC-NBP PHARM | RX | 详细信息 |
| BENZONATATE | 202765 | 001 | ANDA | BENZONATATE | CAPSULE;ORAL | 200MG | No | No | AA | 2015/07/31 | CSPC-NBP PHARM | RX | 详细信息 |
| BENZONATATE | 040682 | 001 | ANDA | BENZONATATE | CAPSULE;ORAL | 100MG | No | No | AA | 2007/07/30 | HERITAGE PHARMS LABS | RX | 详细信息 |
| BENZONATATE | 040682 | 002 | ANDA | BENZONATATE | CAPSULE;ORAL | 200MG | No | No | AA | 2007/07/30 | HERITAGE PHARMS LABS | RX | 详细信息 |
| BENZONATATE | 040851 | 001 | ANDA | BENZONATATE | CAPSULE;ORAL | 100MG | No | No | 2009/11/09 | MIKART | DISCN | 详细信息 | |
| BENZONATATE | 040851 | 002 | ANDA | BENZONATATE | CAPSULE;ORAL | 150MG | No | No | 2009/11/09 | MIKART | DISCN | 详细信息 | |
| BENZONATATE | 040851 | 003 | ANDA | BENZONATATE | CAPSULE;ORAL | 200MG | No | No | 2009/11/09 | MIKART | DISCN | 详细信息 | |
| BENZONATATE | 040795 | 001 | ANDA | BENZONATATE | CAPSULE;ORAL | 100MG | No | No | 2007/10/31 | NESHER PHARMS | DISCN | 详细信息 |
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