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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/06/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 38693 | VARENICLINE TARTRATE | 2023-08-30 | Active | II | N/A | ||
28/06/2025 | Lee Pharma |
India |
LEE PHARMA LTD | 31576 | VARENICLINE BASE (INTERMEDIATE OF VARENICLINE) | 2017-03-30 | Active | II | N/A |