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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
25/04/2025 Otsuka Chemical Co Ltd
Japan
OTSUKA CHEMICAL INDIA PRIVATE LTD 22722 P-METHOXYBENZYL (6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE GCLE CHEMICAL SUBSTANCE 2009-04-13 Active II N/A