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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | FARMAK, a.s |
Czech Republic |
FARMAK AS | 15525 | TIZANIDINE HCL | 2001-07-04 | Active | II | Complete | 2015-03-03 | 2014-10-14 |
28/10/2024 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 15699 | TIZANIDINE HYDROCHLORIDE USP | 2001-11-02 | Active | II | Complete | 2014-01-23 | 2013-04-12 |
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