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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | FARMAK, a.s |
Czech Republic |
FARMAK AS | 12558 | KETOROLAC TROMETHAMINE | 1997-06-17 | Active | II | N/A | ||
| 31/10/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 14603 | KETOROLAC TROMETHAMINE USP | 1999-11-23 | Active | II | Complete | 2013-01-30 | 2013-01-04 |
