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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | Concord Biotech |
India |
CONCORD BIOTECH LTD | 34247 | DACTINOMYCIN USP | 2019-11-06 | Active | II | Complete | 2020-02-04 | 2019-10-25 |
24/02/2025 | SAFC |
U.S.A |
SIGMA ALDRICH ISRAEL LTD | 3538 | DACTINOMYCIN USP | 1979-04-03 | Active | II | N/A |