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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 | SPI Pharma |
U.S.A |
SPI PHARMA INC | 16037 | PHARMABURST® B SERIES PRODUCTS | 2002-07-03 | Active | IV | N/A | ||
24/02/2025 | Pfanstiehl |
U.S.A |
PFANSTIEHL INC | 32464 | D-MANNITOL (PLANT DERIVED) HIGH PURITY / LOW ENDOTOXIN-LOW METALS USP/EP/JP/CHP (M-109-7) | 2018-02-15 | Active | IV | N/A |