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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
30/12/2025 Inke S.A
Spain
INKE SA 38558 OLODATEROL HYDROCHLORIDE 2023-07-21 Active II Complete 2023-08-23 2023-07-12
01/01/2026 Breathgreen Pharmaceuticals
China
BREATHGREEN PHARMACEUTICAL CO LTD 42431 OLODATEROL HYDROCHLORIDE (PROCESS 2) 2025-09-12 Active II N/A