| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LACTULOSE | 017906 | 001 | NDA | LACTULOSE | SOLUTION;ORAL, RECTAL | 10GM/15ML | No | No | -- | Approved Prior to Jan 1, 1982 | SOLVAY | Discontinued |
| LACTULOSE | 071841 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No | -- | 1988/09/22 | MORTON GROVE | Discontinued |
| LACTULOSE | 072029 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL, RECTAL | 10GM/15ML | No | No | -- | 1992/08/25 | PACO | Discontinued |
| LACTULOSE | 073160 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No | -- | 1992/08/25 | PACO | Discontinued |
| LACTULOSE | 073590 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL, RECTAL | 10GM/15ML | No | No | 1992/05/29 | 1992/05/29 | ROXANE | Discontinued |
| LACTULOSE | 073591 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No | 1992/05/29 | 1992/05/29 | HIKMA | Discontinued |
| LACTULOSE | 074138 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No | 1992/09/30 | 1992/09/30 | VISTAPHARM | Discontinued |
| LACTULOSE | 074076 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No | 1995/07/03 | 1995/07/03 | HIKMA | Discontinued |
| LACTULOSE | 074077 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL, RECTAL | 10GM/15ML | No | No | 1995/07/03 | 1995/07/03 | PAI HOLDINGS PHARM | Discontinued |
| LACTULOSE | 074623 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | Yes | 1996/07/30 | 1996/07/30 | PHARM ASSOC | Prescription |
| LACTULOSE | 074602 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No | 1996/11/14 | 1996/11/14 | AUROBINDO PHARMA LTD | Prescription |
| LACTULOSE | 074712 | 001 | ANDA | LACTULOSE | FOR SOLUTION;ORAL | 10GM/PACKET | No | Yes | 1997/12/10 | 1997/12/10 | CUMBERLAND PHARMS | Prescription |
| LACTULOSE | 074712 | 002 | ANDA | LACTULOSE | FOR SOLUTION;ORAL | 20GM/PACKET | No | Yes | 1997/12/10 | 1997/12/10 | CUMBERLAND PHARMS | Prescription |
| LACTULOSE | 075993 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No | 2001/07/26 | 2001/07/26 | LANNETT CO INC | Prescription |
| LACTULOSE | 075911 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No | 2002/02/21 | 2002/02/21 | XTTRIUM LABS INC | Prescription |
| LACTULOSE | 076645 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL, RECTAL | 10GM/15ML | No | No | 2003/07/28 | 2003/07/28 | BAJAJ | Prescription |
| LACTULOSE | 078430 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No | 2007/11/28 | 2007/11/28 | ANI PHARMS | Discontinued |
| LACTULOSE | 090426 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL, RECTAL | 10GM/15ML | No | No | 2008/11/21 | 2008/11/21 | ANI PHARMS | Discontinued |
| LACTULOSE | 090502 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL, RECTAL | 10GM/15ML | No | Yes | 2012/01/25 | 2012/01/25 | FRESENIUS KABI | Prescription |
| LACTULOSE | 090503 | 001 | ANDA | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No | 2012/01/25 | 2012/01/25 | FRESENIUS KABI | Prescription |