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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
28/03/2025 Inke S.A
Spain
INKE SA 35498 VILANTEROL TRIFENATATE 2023-03-16 Active II Complete 2023-05-19 2023-01-09
28/03/2025 Neuland Laboratories
India
NEULAND LABORATORIES LTD 36450 VILANTEROL TRIFENATATE 2022-01-07 Active II N/A