FDA Orange Book · active-ingredient family
Lactulose
Lactulose: 3 brands, 35 generics; first approved Jul 26, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 35 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
35
Listed patents
0
Presentations
40
Brand (NDA) products
Originator applications
- CHRONULACRLDSANOFI AVENTIS USNDA 017884—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - CEPHULACRLDSANOFI AVENTIS USNDA 017657—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued — - LACTULOSESOLVAYNDA 017906—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued —
Generic (ANDA) products (35)
Abbreviated applications
- LACTULOSEPAI HOLDINGSANDA 21791420252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/PACKET FOR SOLUTION ORAL Rx AA 20GM/PACKET FOR SOLUTION ORAL Rx AA - LACTULOSETAROANDA 2188582024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Rx AA - LACTULOSECHARTWELL RXANDA 2095172018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Rx AA - LACTULOSEAPOZEAL PHARMSANDA 2077862018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Rx AA - LACTULOSEAPOZEAL PHARMSANDA 2037622015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Rx AA - LACTULOSEFRESENIUS KABIANDA 0905032012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Rx AA - LACTULOSERSFRESENIUS KABIANDA 0905022012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Rx AA - LACTULOSEANI PHARMSANDA 0904262008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued — - LACTULOSEANI PHARMSANDA 0784302007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - LACTULOSEBAJAJANDA 0766452003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Rx AA - LACTULOSEPHARMOBEDIENTANDA 0759112002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Rx AA - LACTULOSELANNETT CO INCANDA 0759932001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Rx AA - LACTULOSERSAPOTEXANDA 07471219972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/PACKET FOR SOLUTION ORAL Rx AA 20GM/PACKET FOR SOLUTION ORAL Rx AA - LACTULOSEAUROBINDO PHARMA LTDANDA 0746021996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Rx AA - CHARTWELL RXANDA 0746031996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Rx AA - LACTULOSERSPHARM ASSOCANDA 0746231996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Rx AA - LACTULOSEHIKMAANDA 0740761995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - LACTULOSEPAI HOLDINGS PHARMANDA 0740771995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued — - TEVA PHARMSANDA 0734971993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - NOSTRUM LABSANDA 0736861993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - NOSTRUM LABSANDA 0736851993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued — - TEVA PHARMSANDA 0735041993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued — - LACTULOSEVISTAPHARM LLCANDA 0741381992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - LACTULOSEPACOANDA 0731601992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - LACTULOSEPACOANDA 0720291992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued — - LACTULOSEHIKMAANDA 0735911992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - LACTULOSEROXANEANDA 0735901992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued — - SOLVAYANDA 0723721989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - SOLVAYANDA 0723741989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued — - MORTON GROVEANDA 0718421988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued — - LACTULOSEMORTON GROVEANDA 0718411988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - ACTAVIS MID ATLANTICANDA 0702881988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - ACTAVIS MID ATLANTICANDA 0715481988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued — - ALRAANDA 0710541988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL Discontinued — - ALRAANDA 0713311988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10GM/15ML SOLUTION ORAL, RECTAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
38 yr 9 mo ago
Most recent approval
1 yr 7 mo ago
Approvals span 1988–2025 across 38 FDA applications.
Brand (NDA) 38%
Generic (ANDA) 3592%
Lactulose: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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