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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 | Veranova |
U.S.A |
VERANOVA LP | 27700 | DIPHENOXYLATE HCL | 2014-01-20 | Active | II | Complete | 2015-09-03 | 2013-11-19 |
28/03/2025 | Mallinckrodt Pharmaceuticals |
Ireland |
SPECGX LLC | 12441 | DIPHENOXYLATE HYDROCHLORIDE USP | 1997-03-31 | Active | II | Complete | 2014-05-22 | 2014-03-05 |