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    List of Drug Master Files (DMF) for 29383 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Covalent Laboratories Private Limited

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    01 Covalent Laboratories Private Limited (1)

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    01 CEFPROZIL USP (1)

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    COVALENT LABORATORIES PRIVATE LTD

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      CEFPROZIL USP

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      29383
      Active
      2015-05-15
      Complete
      2017-07-11
      2017-05-31
      II
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      Looking for Drug Master Files (DMF) for 29383 of Covalent Laboratories Private Ltd

      Looking for Drug Master Files (DMF) for 29383 of Covalent Laboratories Private Ltd 1

      20

      Covalent Laboratories Private Ltd, based in India, is a pharmaceutical company.

      One of their notable products is CEFPROZIL USP, with a corresponding US DMF Number 29383.

      Remarkably, this DMF maintains an Active status since its submission on May 15, 2015, highlighting commitment to regulatory compliance.

      Their GDUFA DMF Review was successfully complete, with a review date of July 11, 2017, and payment made on May 31, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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