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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 Symbiotec Pharmalab
India
SYMBIOTEC PHARMALAB PRIVATE LTD 37466 BETAMETHASONE SODIUM PHOSPHATE USP 2022-09-09 Active II Complete 2023-10-25 2023-10-03
28/11/2024 ACS DOBFAR SPA
Italy
ANTIBIOTICOS SPA 2377 BETAMETHASONE SODIUM PHOSPHATE, N.F. XIII BULK 1974-12-18 Inactive II N/A