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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 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 30663 | PREGABALIN USP | 2016-06-28 | Active | II | Complete | 2016-09-01 | 2016-07-14 |
24/02/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 22242 | PREGABALIN DRUG SUBSTANCE | 2008-12-01 | Active | II | Complete | 2012-11-23 | 2012-11-13 |