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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 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 33405 | NALOXEGOL OXALATE PREMIX | 2018-12-01 | Active | II | Complete | 2019-01-29 | 2018-11-30 |
25/04/2025 | MSN Laboratories |
India |
MSN LIFE SCIENCES PRIVATE LTD | 32535 | NALOXEGOL OXALATE | 2018-03-03 | Active | II | Complete | 2018-06-19 | 2018-04-04 |