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    Approved Drug Products containing Lactulose listed in the FDA Orange Book. Original Data : FDA Website

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    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Bora Pharmaceuticals- Making success more certain.

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    Axplora- The partner of choice for complex APIs.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Lactulose

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    01 2SANOFI AVENTIS US

    02 2ACTAVIS MID ATLANTIC

    03 2ALRA

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    06 1AUROBINDO PHARMA LTD

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    18 1ROXANE

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    01

    SANOFI AVENTIS US

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    RLD : Yes

    TE Code :

    LACTULOSE

    Brand Name : CEPHULAC

    Dosage Form : SOLUTION;ORAL, RECTAL

    Dosage Strength : 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1982-01-01

    Application Number : 17657

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    02

    SANOFI AVENTIS US

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    RLD : Yes

    TE Code :

    LACTULOSE

    Brand Name : CHRONULAC

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1982-01-01

    Application Number : 17884

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    03

    ACTAVIS MID ATLANTIC

    Ireland
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    Not Confirmed
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    ACTAVIS MID ATLANTIC

    Ireland
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    RLD : No

    TE Code :

    LACTULOSE

    Brand Name : CONSTULOSE

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 10GM/15ML

    Approval Date : 1988-08-15

    Application Number : 70288

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    04

    ACTAVIS MID ATLANTIC

    Ireland
    Luxepack
    Not Confirmed
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    ACTAVIS MID ATLANTIC

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    RLD : No

    TE Code :

    LACTULOSE

    Brand Name : ENULOSE

    Dosage Form : SOLUTION;ORAL, RECTAL

    Dosage Strength : 10GM/15ML

    Approval Date : 1988-08-15

    Application Number : 71548

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    05

    ALRA

    United Kingdom
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    Not Confirmed
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    ALRA

    United Kingdom
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    RLD : No

    TE Code :

    LACTULOSE

    Brand Name : CONSTILAC

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 10GM/15ML

    Approval Date : 1988-07-26

    Application Number : 71054

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    06

    ALRA

    United Kingdom
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    Not Confirmed
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    ALRA

    United Kingdom
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    RLD : No

    TE Code :

    LACTULOSE

    Brand Name : CHOLAC

    Dosage Form : SOLUTION;ORAL, RECTAL

    Dosage Strength : 10GM/15ML

    Approval Date : 1988-07-26

    Application Number : 71331

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    07

    MORTON GROVE

    U.S.A
    Luxepack
    Not Confirmed
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    MORTON GROVE

    U.S.A
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    Luxepack
    Not Confirmed
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    RLD : No

    TE Code :

    LACTULOSE

    Brand Name : LACTULOSE

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 10GM/15ML

    Approval Date : 1988-09-22

    Application Number : 71841

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    08

    MORTON GROVE

    U.S.A
    Luxepack
    Not Confirmed
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    MORTON GROVE

    U.S.A
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    RLD : No

    TE Code :

    LACTULOSE

    Brand Name : GENERLAC

    Dosage Form : SOLUTION;ORAL, RECTAL

    Dosage Strength : 10GM/15ML

    Approval Date : 1988-09-27

    Application Number : 71842

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    09

    SOLVAY

    Belgium
    Luxepack
    Not Confirmed
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    SOLVAY

    Belgium
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    Not Confirmed
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    RLD : No

    TE Code :

    LACTULOSE

    Brand Name : LACTULOSE

    Dosage Form : SOLUTION;ORAL, RECTAL

    Dosage Strength : 10GM/15ML

    Approval Date : 1982-01-01

    Application Number : 17906

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    PACO

    U.S.A
    Luxepack
    Not Confirmed
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    PACO

    U.S.A
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    Luxepack
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    RLD : No

    TE Code :

    LACTULOSE

    Brand Name : LACTULOSE

    Dosage Form : SOLUTION;ORAL, RECTAL

    Dosage Strength : 10GM/15ML

    Approval Date : 1992-08-25

    Application Number : 72029

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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