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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 | Sandoz B2B |
Switzerland |
SANDOZ GMBH | 24988 | FILGRASTIM (G-CSF) | 2011-05-27 | Inactive | II | N/A | ||
28/03/2025 | Therapeutic Proteins International, LLC |
U.S.A |
KASHIV BIOSCIENCES LLC | 25947 | COMPOUND FILGRASTIM (G-CSF) CONCENTRATED SOLUTION, EP | 2012-05-17 | Active | II | N/A |