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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 | Aspen API |
Netherlands |
FINE CHEMICALS CORP PTY LTD | 14411 | PENBUTOLOL SULFATE | 1999-09-17 | Active | II | Complete | 2014-12-02 | 2013-12-03 |
| 28/03/2025 | HOECHST-ROUSSEL PHARMACEUTICALS INC | 4618 | PENBUTOLOL SULFATE (BULK FORM) | 1982-08-06 | Inactive | II | N/A |
