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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 | Cohance Lifesciences |
India |
COHANCE LIFESCIENCES LTD | 29211 | ATOMOXETINE HYDROCHLORIDE USP | 2015-03-26 | Active | II | Complete | 2019-12-27 | 2019-12-03 |
28/03/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 18440 | ATOMOXETINE HYDROCHLORIDE USP | 2005-06-22 | Active | II | N/A |