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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 | Minakem (formerly Delmar Chemicals) |
Canada |
DELMAR CHEMICALS INC | 16243 | MONTELUKAST SODIUM THIOL ACID | 2002-11-15 | Active | II | N/A | ||
| 28/03/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 24516 | MONTELUKAST SODIUM [PROCESS-2] | 2010-12-31 | Active | II | Complete | 2015-02-18 | 2012-12-31 |
