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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 | Aspen API |
Netherlands |
FINE CHEMICALS CORP PTY LTD | 6914 | BENZTROPINE MESYLATE | 1987-04-09 | Active | II | Complete | 2012-10-25 | 2012-12-19 |
28/03/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 7033 | BENZTROPINE MESYLATE USP | 1987-06-18 | Active | II | Complete | 2021-04-02 | 2021-03-30 |