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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 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 25528 | NEPAFENAC, NON-STERILE BULK DRUG SUBSTANCE | 2014-12-17 | Active | II | N/A | ||
28/03/2025 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 28205 | NEPAFENAC, STERILE BULK DRUG SUBSTANCE | 2015-12-29 | Active | II | N/A |