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List of Drug Master Files (DMF) of Hydromorphone 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 Veranova
U.S.A
VERANOVA LP 19846 HYDROMORPHONE HCI, USP 2006-10-06 Active II Complete 2014-06-06 2014-05-28
26/09/2024 Noramco
U.S.A
NORAMCO LLC 19561 HYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE 2006-06-29 Active II Complete 2013-02-06 2012-11-23