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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Dipharma |
Italy |
DIPHARMA FRANCIS SRL | 5404 | DOXEPIN HCl | 1984-04-10 | Active | II | Complete | 2014-03-31 | 2014-03-24 |
28/10/2024 | GSK |
United Kingdom |
SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP | 4494 | DOXEPIN HCL | 1982-03-10 | Inactive | II | N/A |
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