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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(ANDA) 071331 | 001 | CHOLAC | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | ALRA | 1988-07-26 | No | No | DISCN | |
(ANDA) 072029 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | PACO | 1992-08-25 | No | No | DISCN | |
(ANDA) 203762 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | APOZEAL PHARMS | 2015-03-27 | No | No | RX | AA |
(ANDA) 090426 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | ANI PHARMS | 2008-11-21 | No | No | DISCN | |
(ANDA) 071842 | 001 | GENERLAC | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | MORTON GROVE | 1988-09-27 | No | No | DISCN | |
(ANDA) 074603 | 001 | GENERLAC | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | CHARTWELL RX | 1996-10-31 | No | No | RX | AA |
(ANDA) 073590 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | ROXANE | 1992-05-29 | No | No | DISCN | |
(ANDA) 090502 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | FRESENIUS KABI | 2012-01-25 | No | Yes | RX | AA |
(ANDA) 073504 | 001 | HEPTALAC | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | TEVA PHARMS | 1993-05-28 | No | No | DISCN | |
(ANDA) 071548 | 001 | ENULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | ACTAVIS MID ATLANTIC | 1988-08-15 | No | No | DISCN | |
(NDA) 017657 | 001 | CEPHULAC | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SANOFI AVENTIS US | 1982-01-01 | Yes | No | DISCN | |
(ANDA) 073685 | 001 | ACILAC | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | NOSTRUM LABS | 1993-05-28 | No | No | DISCN | |
(NDA) 017906 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | SOLVAY | 1982-01-01 | No | No | DISCN | |
(ANDA) 076645 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | BAJAJ | 2003-07-28 | No | No | RX | AA |
(ANDA) 072374 | 001 | PORTALAC | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | SOLVAY | 1989-03-22 | No | No | DISCN | |
(ANDA) 074077 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL, RECTAL | 10GM/15ML | PAI HOLDINGS PHARM | 1995-07-03 | No | No | DISCN | |
(ANDA) 073591 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL | 10GM/15ML | HIKMA | 1992-05-29 | No | No | DISCN | |
(ANDA) 090503 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL | 10GM/15ML | FRESENIUS KABI | 2012-01-25 | No | No | RX | AA |
(ANDA) 209517 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL | 10GM/15ML | CHARTWELL RX | 2018-11-23 | No | No | RX | AA |
(ANDA) 074602 | 001 | LACTULOSE | LACTULOSE | 乳果糖 | SOLUTION;ORAL | 10GM/15ML | AUROBINDO PHARMA LTD | 1996-11-14 | No | No | RX | AA |