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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 | Bachem AG |
Switzerland |
BACHEM AMERICAS INC | 28532 | VASOPRESSIN, USP (BULK) | 2014-08-01 | Active | II | Complete | 2017-09-29 | 2017-08-24 |
28/10/2024 | Amphastar Pharmaceuticals |
U.S.A |
INTERNATIONAL MEDICATION SYSTEMS LTD | 32769 | VASOPRESSIN USP | 2018-05-05 | Active | II | Complete | 2018-07-13 | 2018-05-04 |
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