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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
27/09/2025 | Roquette |
France |
ROQUETTE FRERES | 6244 | POLYSORB 85/70/00 (SORBITOL SORBITAN SOLUTION) | 1986-04-03 | Active | IV | N/A | ||
27/09/2025 | SPI PHARMA INC |
Gabon |
SPI PHARMA INC | 11651 | SORBITOL SPECIAL (PLASTICIZER) | 1996-01-03 | Inactive | IV | N/A |