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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 | Apicore |
India |
APICORE US LLC | 23631 | BEXAROTENE | 2010-04-26 | Active | II | Complete | 2015-08-07 | 2015-07-29 |
28/03/2025 | Catalent Pharma Solutions |
U.S.A |
CATALENT PHARMA SOLUTIONS LLC | 14086 | TARGRETIN 75 MG SOFT-GELATIN CAPSULE | 1999-04-19 | Inactive | II | N/A |