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    List of Drug Master Files (DMF) for 26359 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Chromo Laboratories

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    01 ZAFIRLUKAST PREMIX-50% W/W (1)

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    CHROMO LABORATORIES INDIA PRIVATE L...

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      ZAFIRLUKAST PREMIX-50% W/W

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      26359
      Active
      2012-09-28
      Complete
      2018-12-20
      2018-12-18
      II
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      Looking for Drug Master Files (DMF) for 26359 of Chromo Laboratories India Private Ltd

      Looking for Drug Master Files (DMF) for 26359 of Chromo Laboratories India Private Ltd 1

      20

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

      One of their notable products is ZAFIRLUKAST PREMIX-50% W/W, with a corresponding US DMF Number 26359.

      Remarkably, this DMF maintains an Active status since its submission on September 28, 2012, highlighting commitment to regulatory compliance.

      Their GDUFA DMF Review was successfully complete, with a review date of December 20, 2018, and payment made on December 18, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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