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    List of Drug Master Files (DMF) for 12697 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    W R GRACE AND CO -CONN

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      ITRACONAZOLE USP & PH EUR

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      URL Supplier Web Content
      12697
      Active
      1997-10-16
      Complete
      2018-02-08
      2017-12-28
      II
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      Looking for Drug Master Files (DMF) for 12697 of W R Grace And Co -conn

      Looking for Drug Master Files (DMF) for 12697 of W R Grace And Co -conn 1

      20

      W R Grace And Co -conn, based in U.S.A, is a pharmaceutical company.

      One of their notable products is ITRACONAZOLE USP & PH EUR, with a corresponding US DMF Number 12697.

      Remarkably, this DMF maintains an Active status since its submission on October 16, 1997, highlighting commitment to regulatory compliance.

      Their GDUFA DMF Review was successfully complete, with a review date of February 08, 2018, and payment made on December 28, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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