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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 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 13713 | TOBRAMYCIN | 1998-09-01 | Active | II | Complete | 2012-12-26 | 2012-11-13 |
28/03/2025 | Actavis Inc |
Ireland |
ALPHARMA APS | 19029 | TOBRAMYCIN BASE USP (NON-STERILE BULK) | 2005-12-09 | Inactive | II | N/A |