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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 | Bachem AG |
Switzerland |
BACHEM AMERICAS INC | 16760 | OCTREOTIDE ACETATE USP | 2003-08-13 | Active | II | Complete | 2015-09-09 | 2014-04-10 |
28/03/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 17777 | OCTREOTIDE ACETATE | 2004-10-21 | Active | II | Complete | 2015-02-27 | 2012-11-09 |