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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/11/2024 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 31477 | ZIPRASIDONE MESILATE TRIHYDRATE | 2018-10-10 | Active | II | Complete | 2018-11-26 | 2018-10-18 |
28/11/2024 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 38745 | ZIPRASIDONE MESYLATE TRIHYDRATE | 2023-08-23 | Active | II | Complete | 2023-10-12 | 2023-08-22 |
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