Sold as Cephulac, Chronulac, Lactulose. Every FDA application for this active ingredient: 3 branded and 35 generic.
As of Nov 13, 2026, FDA lists 38 applications for Lactulose (sold as Cephulac, Chronulac, Lactulose), first approved Mar 25, 1976, with 1 new use approved and 0 published complete response letters.
| Lactulose | Part D | $66.7M | +10% | 568,507 |
| Constulose | Part D | $6.7M | +33% | 119,473 |
| Enulose | Part D | $6.3M | +12% | 92,595 |
| Kristalose | Part D | $2.8M | -29% | 2,757 |
| Generlac | Part D | $27K | -27% | 428 |
| Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With EndometriosisSIBO, Endometriosis · Insel Gruppe AG, University Hospital Bern | Not applicable | Not yet recruiting | Nov 6, 2026 |
| Evaluating the Impact of Vitamin D Supplementation on Healing Bed Sores in ICU.Bed Sores · Maha Salah | Not applicable | Recruiting | Sep 10, 2026 |
| Breath Gases, Gut Flora, and Immunity in Children With ConstipationConstipation - Functional · Ruijin Hospital | — | Active, not recruiting | Sep 1, 2026 |
| Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel SyndromeIrritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth Syndrome (SIBO) · Johns Hopkins University | Phase 2 | Enrolling by invitation | Aug 17, 2026 |
| Fecal Microbiota Transplantation for the Treatment of Refractory Hepatic Encephalopathy After TIPS SurgeryHepatic Encephalopathy, Fecal Microbiota Transplantation · Air Force Military Medical University, China | Early phase 1 | Recruiting | Jul 6, 2026 |
| Gut Permeability and Microbiome in Preterm InfantsPrematurity Complications · University of Maryland, Baltimore | Phase 1 | Recruiting | Jun 24, 2026 |
| Research on the Efficacy and Mechanism of Shouhui Tongbian Capsules in Treating Postoperative Constipation of Benign Anal and Rectal Diseases Based on Gut Microbiota AnalysisIntestinal Flora, Anorectal Diseases · China-Japan Friendship Hospital | Phase 1 / Phase 2 | Not yet recruiting | Jun 15, 2026 |
| Oral Lactulose for Gastrointestinal Recovery After Complex AppendectomyIleus Postoperative, Gastrointestinal Function · Nanchong Central Hospital | Not applicable | Recruiting | May 15, 2026 |
| Mar 25, 1976 | CephulacNDA 17657 · New molecular entity | Sanofi Aventis US | 29 | Discontinued |
| Jun 20, 1979 | ChronulacNDA 17884 · New formulation or manufacturer | Sanofi Aventis US | 20 | Discontinued |
| Jul 26, 1988 | ConstilacANDA 71054 | Alra | 4 | Discontinued |
| Jul 26, 1988 | CholacANDA 71331 | Alra | 5 | Discontinued |
| Aug 15, 1988 | ConstuloseANDA 70288 | Actavis Mid Atlantic | 16 | Discontinued |
| Aug 15, 1988 | EnuloseANDA 71548 | Actavis Mid Atlantic | 13 | Discontinued |
| May 29, 1992 | LactuloseANDA 73590 | Roxane | 0 | Discontinued |
| May 29, 1992 | LactuloseANDA 73591 | Hikma | 15 | Discontinued |
| Sep 30, 1992 | LactuloseANDA 74138 | Vistapharm LLC | 12 | Discontinued |
| May 28, 1993 | EvaloseANDA 73497 | Teva Pharms | 3 | Discontinued |
| May 28, 1993 | HeptalacANDA 73504 | Teva Pharms | 3 | Discontinued |
| May 28, 1993 | AcilacANDA 73685 | Nostrum Labs | 12 | Discontinued |
| May 28, 1993 | LaxiloseANDA 73686 | Nostrum Labs | 10 | Discontinued |
| Jul 3, 1995 | LactuloseANDA 74077 | Pai Holdings Pharm | 5 | Discontinued |
| Jul 3, 1995 | LactuloseANDA 74076 | Hikma | 5 | Discontinued |
| Jul 30, 1996 | LactuloseANDA 74623 | Pharm Assoc | 3 | Marketed |
| Oct 31, 1996 | GenerlacANDA 74603 | Chartwell Rx | 5 | Marketed |
| Nov 14, 1996 | LactuloseANDA 74602 | Aurobindo Pharma Ltd | 3 | Marketed |
| Dec 10, 1997 | LactuloseANDA 74712 | Apotex | 2 | Marketed |
| Jul 26, 2001 | LactuloseANDA 75993 | Lannett Co Inc | 0 | Marketed |
| Feb 21, 2002 | LactuloseANDA 75911 | Pharmobedient | 1 | Marketed |
| Jul 28, 2003 | LactuloseANDA 76645 | Bajaj | 1 | Marketed |
| Nov 28, 2007 | LactuloseANDA 78430 | Ani Pharms | 0 | Discontinued |
| Nov 21, 2008 | LactuloseANDA 90426 | Ani Pharms | 0 | Discontinued |
| Jan 25, 2012 | LactuloseANDA 90502 | Fresenius Kabi | 0 | Marketed |
| Jan 25, 2012 | LactuloseANDA 90503 | Fresenius Kabi | 0 | Marketed |
| Mar 27, 2015 | LactuloseANDA 203762 | Pharmazone | 1 | Marketed |
| Jun 11, 2018 | LactuloseANDA 207786 | Pharmazone | 1 | Marketed |
| Nov 23, 2018 | LactuloseANDA 209517 | Chartwell Rx | 0 | Marketed |
| Dec 13, 2024 | LactuloseANDA 218858 | Taro | 0 | Marketed |
| Mar 14, 2025 | LactuloseANDA 217914 | Pai Holdings | 0 | Marketed |
| — | LactuloseNDA 17906 | Solvay | 0 | Discontinued |
| — | LactuloseANDA 72029 | Paco | 0 | Discontinued |
| — | LactuloseANDA 71841 | Morton Grove | 0 | Discontinued |
| — | GenerlacANDA 71842 | Morton Grove | 0 | Discontinued |
| — | DuphalacANDA 72372 | Solvay | 0 | Discontinued |
| — | PortalacANDA 72374 | Solvay | 0 | Discontinued |
| — | LactuloseANDA 73160 | Paco | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sanofi Aventis US
Roxane
Hikma
Apotex
Taro