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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 | Alcami |
U.S.A |
STERLING WISCONSIN LLC | 19151 | FP-059 (FOMEPIZOLE) DRUG SUBSTANCE | 2006-02-03 | Active | II | N/A | ||
| 28/03/2025 | Apothecon Pharmaceuticals |
India |
NAVINTA LLC | 19683 | FOMEPIZOLE | 2006-08-10 | Active | II | N/A |
