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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
04/06/2025 | Lonza Inc & Lonza America Inc |
U.S.A |
ARXADA LLC | 24010 | GLYCOMUL TS KFG | 2010-07-27 | Active | IV | N/A | ||
04/06/2025 | ICI AMERICAS INC |
Gabon |
ICI AMERICAS INC | 3399 | TWEEN 65 (SORBITAN TRISTEARATE) (POLYOXYETHYLENE) | 1978-12-07 | Inactive | II | N/A |