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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/06/2025 | Alchem International Private Ltd |
India |
ALCHEM INTERNATIONAL PRIVATE LTD | 38319 | NICOTINE USP (4691A) | 2023-05-18 | Active | II | N/A | ||
28/06/2025 | Actavis Inc |
Ireland |
NICOBRAND LTD | 10739 | NICOTINE POLACRILEX RESIN | 1994-02-01 | Active | II | Complete | 2012-10-25 | 2012-11-26 |