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    List of Drug Master Files (DMF) for 31719 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    CHROMO LABORATORIES INDIA PRIVATE L...

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      TERBINAFINE HYDROCHLORIDE USP

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      31719
      Active
      2017-07-12
      Complete
      2019-06-03
      2019-01-28
      II
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      Looking for Drug Master Files (DMF) for 31719 of Chromo Laboratories India Private Ltd

      Looking for Drug Master Files (DMF) for 31719 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 TERBINAFINE HYDROCHLORIDE USP, with a corresponding US DMF Number 31719.

      Remarkably, this DMF maintains an Active status since its submission on July 12, 2017, highlighting commitment to regulatory compliance.

      Their GDUFA DMF Review was successfully complete, with a review date of June 03, 2019, and payment made on January 28, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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