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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 | PCAS |
France |
PCAS | 28375 | ESOMEPRAZOLE SODIUM | 2014-06-09 | Active | II | N/A | ||
28/11/2024 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 26102 | ESOMEPRAZOLE SODIUM (NON-STERILE DRUG SUBSTANCE) | 2012-09-07 | Active | II | Complete | 2013-07-23 | 2012-12-26 |
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