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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 25/04/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 41503 | DIFELIKEFALIN ACETATE | 2025-03-26 | Active | II | N/A | ||
| 25/04/2025 | Chunghwa Chemical Synthesis & Biotech |
Taiwan |
CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | 38511 | DIFELIKEFALIN ACETATE | 2023-06-19 | Active | II | N/A |
