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List of Drug Master Files (DMF) of Argipressin Tannate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 Bachem AG
Switzerland
BACHEM AMERICAS INC 28532 VASOPRESSIN, USP (BULK) 2014-08-01 Active II Complete 2017-09-29 2017-08-24
26/09/2024 Amphastar Pharmaceuticals
U.S.A
INTERNATIONAL MEDICATION SYSTEMS LTD 32769 VASOPRESSIN USP 2018-05-05 Active II Complete 2018-07-13 2018-05-04