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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
28/10/2024 CSPC CENWAY TIANJIN PHARMACEUTICALS CO LTD
China
CSPC CENWAY TIANJIN PHARMACEUTICALS CO LTD 20146 GCLE (NON-STERILE, BULK FORM) 2007-01-04 Active II N/A
28/10/2024 Otsuka Chemical Co Ltd
Japan
OTSUKA CHEMICAL CO LTD 20451 P-METHOXYBENZYL(6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE, GCLE 2007-04-10 Inactive II N/A