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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | Aspen API |
Netherlands |
ASPEN OSS BV | 7197 | DESOGESTREL | 1987-10-28 | Active | II | Complete | 2013-08-13 | 2013-08-01 |
24/02/2025 | Symbiotec Pharmalab |
India |
SYMBIOTEC PHARMALAB PRIVATE LTD | 28124 | DESOGESTREL EP/BP, MICRONIZED | 2014-03-17 | Active | II | N/A |