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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 | Axplora |
Germany |
PHARMAZELL GMBH | 5836 | N-ACETYL-L-CYSTEINE | 1985-03-29 | Active | II | Complete | 2014-08-07 | 2013-04-03 |
| 28/03/2025 | Moehs Iberica |
Spain |
MOEHS IBERICA SL | 14304 | ACETYLCYSTEINE USP | 1999-07-21 | Active | II | Complete | 2013-01-22 | 2013-01-07 |
