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    List of Drug Master Files (DMF) for 15924 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    BioProcess International
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    Teva Pharmaceutical Industries Ltd

    Israel
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    BioProcess International
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-30

    Pay. Date : 2012-11-09

    DMF Number : 15924

    Submission : 2002-04-04

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 15924 of Teva Pharmaceutical Industries Ltd

    Looking for Drug Master Files (DMF) for 15924 of Teva Pharmaceutical Industries Ltd 1

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    Teva Pharmaceutical Industries Ltd, based in Israel, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Teva API has over 350 products in its portfolio and is the leading international supplier of APIs.

    One of their notable products is LAMOTRIGINE, with a corresponding US DMF Number 15924.

    Remarkably, this DMF maintains an Active status since its submission on April 04, 2002, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 30, 2012, and payment made on November 09, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II