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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | Seqens |
France |
WAVELENGTH ENTERPRISES LTD | 16244 | CETIRIZINE DIHYDROCHLORIDE | 2002-11-14 | Active | II | Complete | 2017-03-03 | 2017-02-08 |
28/03/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 18395 | CETIRIZINE DIHYDROCHLORIDE | 2005-05-27 | Active | II | Complete | 2014-06-16 | 2014-06-06 |