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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 | 2908 | AMITRIPTYLINE HYDROCHLORIDE | 1977-03-18 | Active | II | N/A | ||
28/10/2024 | F. Hoffmann-La Roche |
Switzerland |
KV PHARMACEUTICAL CO | 2413 | AMITRIPTYLINE HYDROCHLORIDE | 1975-03-10 | Inactive | II | N/A |
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