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    List of Drug Master Files (DMF) for 13654 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 Ercros (1)

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    01 ERYTHROMYCIN ETHYLSUCCINATE (1)

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    ERYTHROMYCIN ETHYLSUCCINATE

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    13654
    Active
    1998-09-01
    Complete
    2017-08-01
    2017-07-13
    II
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    Looking for Drug Master Files (DMF) for 13654 of Ercros Sa

    Looking for Drug Master Files (DMF) for 13654 of Ercros Sa 1

    20

    Ercros Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is ERYTHROMYCIN ETHYLSUCCINATE, with a corresponding US DMF Number 13654.

    Remarkably, this DMF maintains an Active status since its submission on September 01, 1998, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 01, 2017, and payment made on July 13, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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