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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 | Arene Lifesciences |
India |
ARENE LIFE SCIENCES PRIVATE LTD | 34471 | DOLUTEGRAVIR SODIUM | 2020-01-31 | Active | II | N/A | ||
28/10/2024 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 28721 | DOLUTEGRAVIR SODIUM | 2014-10-14 | Active | II | Complete | 2015-01-08 | 2014-10-10 |
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