FDA Orange Book · active-ingredient family
Lactulose
Lactulose is approved as 3 brand and 35 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CHRONULAC · NDA 017884
3
Brand (NDA)
35
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHRONULACRLD | SANOFI AVENTIS US | NDA 017884 | — | Approved Prior to Jan 1, 1982 | |
| CEPHULACRLD | SANOFI AVENTIS US | NDA 017657 | — | Approved Prior to Jan 1, 1982 | |
| LACTULOSE | SOLVAY | NDA 017906 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (35)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LACTULOSE×2 | PAI HOLDINGS | ANDA 217914 | AA | Mar 14, 2025 | |
| LACTULOSE | TARO | ANDA 218858 | AA | Dec 13, 2024 | |
| LACTULOSE | CHARTWELL RX | ANDA 209517 | AA | Nov 23, 2018 | |
| LACTULOSE | APOZEAL PHARMS | ANDA 207786 | AA | Jun 11, 2018 | |
| LACTULOSE | SCIEGEN PHARMS | ANDA 203762 | AA | Mar 27, 2015 | |
| LACTULOSE | FRESENIUS KABI | ANDA 090503 | AA | Jan 25, 2012 | |
| LACTULOSE | FRESENIUS KABI | ANDA 090502 | AA | Jan 25, 2012 | |
| LACTULOSE | ANI PHARMS | ANDA 090426 | — | Nov 21, 2008 | |
| LACTULOSE | ANI PHARMS | ANDA 078430 | — | Nov 28, 2007 | |
| LACTULOSE | BAJAJ | ANDA 076645 | AA | Jul 28, 2003 | |
| LACTULOSE | PHARMOBEDIENT | ANDA 075911 | AA | Feb 21, 2002 | |
| LACTULOSE | LANNETT CO INC | ANDA 075993 | AA | Jul 26, 2001 | |
| LACTULOSE×2 | CUMBERLAND PHARMS | ANDA 074712 | AA | Dec 10, 1997 | |
| LACTULOSE | AUROBINDO PHARMA LTD | ANDA 074602 | AA | Nov 14, 1996 | |
| GENERLAC | CHARTWELL RX | ANDA 074603 | AA | Oct 31, 1996 | |
| LACTULOSE | PHARM ASSOC | ANDA 074623 | AA | Jul 30, 1996 | |
| LACTULOSE | HIKMA | ANDA 074076 | — | Jul 03, 1995 | |
| LACTULOSE | PAI HOLDINGS PHARM | ANDA 074077 | — | Jul 03, 1995 | |
| EVALOSE | TEVA PHARMS | ANDA 073497 | — | May 28, 1993 | |
| LAXILOSE | NOSTRUM LABS | ANDA 073686 | — | May 28, 1993 | |
| ACILAC | NOSTRUM LABS | ANDA 073685 | — | May 28, 1993 | |
| HEPTALAC | TEVA PHARMS | ANDA 073504 | — | May 28, 1993 | |
| LACTULOSE | VISTAPHARM LLC | ANDA 074138 | — | Sep 30, 1992 | |
| LACTULOSE | PACO | ANDA 073160 | — | Aug 25, 1992 | |
| LACTULOSE | PACO | ANDA 072029 | — | Aug 25, 1992 | |
| LACTULOSE | HIKMA | ANDA 073591 | — | May 29, 1992 | |
| LACTULOSE | ROXANE | ANDA 073590 | — | May 29, 1992 | |
| DUPHALAC | SOLVAY | ANDA 072372 | — | Mar 22, 1989 | |
| PORTALAC | SOLVAY | ANDA 072374 | — | Mar 22, 1989 | |
| GENERLAC | MORTON GROVE | ANDA 071842 | — | Sep 27, 1988 | |
| LACTULOSE | MORTON GROVE | ANDA 071841 | — | Sep 22, 1988 | |
| CONSTULOSE | ACTAVIS MID ATLANTIC | ANDA 070288 | — | Aug 15, 1988 | |
| ENULOSE | ACTAVIS MID ATLANTIC | ANDA 071548 | — | Aug 15, 1988 | |
| CONSTILAC | ALRA | ANDA 071054 | — | Jul 26, 1988 | |
| CHOLAC | ALRA | ANDA 071331 | — | Jul 26, 1988 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Lactulose — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
