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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 27/09/2025 | Veranova |
U.S.A |
VERANOVA LP | 15059 | D-THREO-METHYLPHENIDATE HYDROCHLORIDE | 2000-09-22 | Active | II | N/A | ||
| 27/09/2025 | Alkem Laboratories |
India |
ALKEM LABORATORIES LTD | 32902 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2018-06-23 | Active | II | Complete | 2018-09-10 | 2018-06-28 |
