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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 | Noramco |
U.S.A |
NORAMCO LLC | 21084 | TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE | 2008-01-23 | Active | II | Complete | 2020-08-05 | 2020-07-30 |
28/10/2024 | Alkem Laboratories |
India |
ALKEM LABORATORIES LTD | 31435 | TAPENTADOL HYDROCHLORIDE | 2017-03-27 | Active | II | Complete | 2017-08-18 | 2017-03-30 |
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