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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
28/10/2024 Aspen API
Netherlands
FINE CHEMICALS CORP PTY LTD 14411 PENBUTOLOL SULFATE 1999-09-17 Active II Complete 2014-12-02 2013-12-03
28/10/2024 HOECHST-ROUSSEL PHARMACEUTICALS INC 4618 PENBUTOLOL SULFATE (BULK FORM) 1982-08-06 Inactive II N/A