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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
30/12/2024 | Interquim SA |
Spain |
INTERQUIM SA | 34969 | ARIPIPRAZOLE MONOHYDRATE | 2021-03-31 | Active | II | Complete | 2021-11-17 | 2020-12-02 |
30/12/2024 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 22889 | ARIPIPRAZOLE USP (ANHYDROUS FORM - B) | 2009-06-24 | Active | II | Complete | 2021-11-18 | 2021-08-10 |
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