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    List of Drug Master Files (DMF) for 21806 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    FIS FABBRICA ITALIANA SINTETICI SPA

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      THALIDOMIDE

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      URL Supplier Web Content
      21806
      Active
      2008-07-28
      Complete
      2016-02-26
      2015-02-17
      II
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      Looking for Drug Master Files (DMF) for 21806 of Fis Fabbrica Italiana Sintetici Spa

      Looking for Drug Master Files (DMF) for 21806 of Fis Fabbrica Italiana Sintetici Spa 1

      20

      Fis Fabbrica Italiana Sintetici Spa, based in Switzerland, is a pharmaceutical company.

      One of their notable products is THALIDOMIDE, with a corresponding US DMF Number 21806.

      Remarkably, this DMF maintains an Active status since its submission on July 28, 2008, highlighting commitment to regulatory compliance.

      Their GDUFA DMF Review was successfully complete, with a review date of February 26, 2016, and payment made on February 17, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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