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    List of Drug Master Files (DMF) for 25075 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 CEFUROXIME AXETIL USP (AMORPHOUS) (1)

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      CEFUROXIME AXETIL USP (AMORPHOUS)

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      25075
      Active
      2011-06-24
      Complete
      2016-06-10
      2016-05-19
      II
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      Looking for Drug Master Files (DMF) for 25075 of Covalent Laboratories Private Ltd

      Looking for Drug Master Files (DMF) for 25075 of Covalent Laboratories Private Ltd 1

      20

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

      One of their notable products is CEFUROXIME AXETIL USP (AMORPHOUS), with a corresponding US DMF Number 25075.

      Remarkably, this DMF maintains an Active status since its submission on June 24, 2011, highlighting commitment to regulatory compliance.

      Their GDUFA DMF Review was successfully complete, with a review date of June 10, 2016, and payment made on May 19, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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