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    List of Drug Master Files (DMF) for 11097 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 DIPHENHYDRAMINE CITRATE, USP (1)

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    W R GRACE AND CO -CONN

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      DIPHENHYDRAMINE CITRATE, USP

      PDF Supplier PDF
      URL Supplier Web Content
      11097
      Active
      1994-09-23
      Complete
      2013-06-06
      2013-05-23
      II
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      Looking for Drug Master Files (DMF) for 11097 of W R Grace And Co -conn

      Looking for Drug Master Files (DMF) for 11097 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 DIPHENHYDRAMINE CITRATE, USP, with a corresponding US DMF Number 11097.

      Remarkably, this DMF maintains an Active status since its submission on September 23, 1994, highlighting commitment to regulatory compliance.

      Their GDUFA DMF Review was successfully complete, with a review date of June 06, 2013, and payment made on May 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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