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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 | Apac Pharmaceutical |
U.S.A |
APAC PHARMACEUTICAL LLC | 28587 | DYCLONINE HYDROCHLORIDE USP | 2015-02-18 | Active | II | Complete | 2017-04-24 | 2015-06-08 |
| 28/03/2025 | ChemPacific Corp |
U.S.A |
CHEMPACIFIC CORP | 19497 | DYCLONINE HYDROCHLORIDE DRUG SUBSTANCE | 2006-03-31 | Active | II | N/A |
