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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
FAMOTIDINE | 075400 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 10MG | No | No | 2005/03/18 | 2005/03/18 | PERRIGO | Over-the-counter |
FAMOTIDINE | 077352 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 40MG | No | No | 2005/07/27 | 2005/07/27 | PERRIGO R AND D | Discontinued |
FAMOTIDINE | 077352 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2005/07/27 | 2005/07/27 | PERRIGO R AND D | Discontinued |
FAMOTIDINE | 077351 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2006/09/25 | 2006/09/25 | PERRIGO R AND D | Over-the-counter |
FAMOTIDINE | 077367 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2006/09/25 | 2006/09/25 | DR REDDYS LABS LTD | Over-the-counter |
FAMOTIDINE | 077367 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 10MG | No | No | 2006/09/25 | 2001/08/17 | DR REDDYS LABS LTD | Over-the-counter |
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 077355 | 001 | ANDA | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | TABLET, CHEWABLE;ORAL | 800MG;10MG;165MG | No | No | 2008/02/06 | 2008/02/06 | PERRIGO R AND D | Over-the-counter |
FAMOTIDINE | 078641 | 001 | ANDA | FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2008/06/25 | 2008/06/25 | MYLAN LABS LTD | Prescription |
FAMOTIDINE PRESERVATIVE FREE | 078642 | 001 | ANDA | FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2008/06/25 | 2008/06/25 | MYLAN LABS LTD | Prescription |
FAMOTIDINE | 078916 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2009/05/22 | 2009/05/22 | ALEMBIC PHARMS LTD | Prescription |
FAMOTIDINE | 078916 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 40MG | No | No | 2009/05/22 | 2009/05/22 | ALEMBIC PHARMS LTD | Prescription |
FAMOTIDINE | 090283 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 10MG | No | No | 2009/11/17 | 2009/11/17 | SUN PHARM INDS LTD | Discontinued |
FAMOTIDINE | 090283 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2009/11/17 | 2009/11/17 | SUN PHARM INDS LTD | Discontinued |
FAMOTIDINE | 091020 | 001 | ANDA | FAMOTIDINE | FOR SUSPENSION;ORAL | 40MG/5ML | No | No | 2010/05/27 | 2010/05/27 | NAVINTA LLC | Prescription |
FAMOTIDINE | 090440 | 001 | ANDA | FAMOTIDINE | FOR SUSPENSION;ORAL | 40MG/5ML | No | No | 2010/06/29 | 2010/06/29 | LUPIN LTD | Prescription |
FAMOTIDINE | 090837 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2010/08/04 | 2010/08/04 | GLENMARK PHARMS INC | Over-the-counter |
FAMOTIDINE | 201695 | 001 | ANDA | FAMOTIDINE | FOR SUSPENSION;ORAL | 40MG/5ML | No | No | 2012/12/17 | 2012/12/17 | NOVEL LABS INC | Prescription |
FAMOTIDINE | 201995 | 001 | ANDA | FAMOTIDINE | FOR SUSPENSION;ORAL | 40MG/5ML | No | No | 2014/05/30 | 2014/05/30 | AKORN | Prescription |
FAMOTIDINE | 206530 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2015/12/22 | 2015/12/22 | AUROBINDO PHARMA LTD | Prescription |
FAMOTIDINE | 206530 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 40MG | No | Yes | 2015/12/22 | 2015/12/22 | AUROBINDO PHARMA LTD | Prescription |