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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
28/11/2024 Inke S.A
Spain
INKE SA 38558 OLODATEROL HYDROCHLORIDE 2023-07-21 Active II Complete 2023-08-23 2023-07-12
28/11/2024 Breathgreen Pharmaceuticals
U.S.A
BREATHGREEN PHARMACEUTICAL CO LTD 38916 OLODATEROL HYDROCHLORIDE 2023-09-22 Active II N/A