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

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 Neuland Laboratories
India
NEULAND LABORATORIES LTD 34294 INDACATEROL MALEATE 2019-12-31 Active II N/A
26/09/2024 Breathgreen Pharmaceuticals
U.S.A
BREATHGREEN PHARMACEUTICAL CO LTD 39765 INDACATEROL MALEATE(MICRONIZED AND NON-MICRONIZED) 2024-03-25 Active II N/A