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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
28/03/2025 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 33405 NALOXEGOL OXALATE PREMIX 2018-12-01 Active II Complete 2019-01-29 2018-11-30
28/03/2025 MSN Laboratories
India
MSN LIFE SCIENCES PRIVATE LTD 32562 NALOXEGOL OXALATE (PREMIX) 2018-03-21 Active II Complete 2018-07-16 2018-04-04