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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 | F.I.S. Fabbrica Italiana Sintetici |
Italy |
FIS FABBRICA ITALIANA SINTETICI SPA | 29441 | INDOMETHACIN SODIUM | 2015-09-30 | Active | II | Complete | 2016-05-31 | 2015-09-30 |
| 28/03/2025 | GLAND PHARMA LIMITED |
India |
GLAND PHARMA LTD | 27282 | INDOMETHACIN SODIUM USP | 2013-10-24 | Active | II | Complete | 2014-12-22 | 2014-11-28 |
