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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 | Johnson & Johnson Innovative Medicine |
U.S.A |
JANSSEN PHARMACEUTICA NV | 17828 | DAPOXETINE HYDROCHLORIDE | 2004-12-15 | Inactive | II | N/A | ||
| 25/04/2025 | Maithri Drugs |
India |
MAITHRI DRUGS PRIVATE LTD | 34632 | DAPOXETINE HYDROCHLORIDE | 2020-02-28 | Active | II | N/A |
