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    List of Drug Master Files (DMF) for 30320 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 CEFDINIR HYDRATE USP (1)

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    COVALENT LABORATORIES PRIVATE LTD

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      CEFDINIR HYDRATE USP

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      30320
      Active
      2016-02-22
      Complete
      2017-01-13
      2016-07-19
      II
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      Looking for Drug Master Files (DMF) for 30320 of Covalent Laboratories Private Ltd

      Looking for Drug Master Files (DMF) for 30320 of Covalent Laboratories Private Ltd 1

      20

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

      One of their notable products is CEFDINIR HYDRATE USP, with a corresponding US DMF Number 30320.

      Remarkably, this DMF maintains an Active status since its submission on February 22, 2016, highlighting commitment to regulatory compliance.

      Their GDUFA DMF Review was successfully complete, with a review date of January 13, 2017, and payment made on July 19, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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