GlobeNewswire PharmaOriginal article
ANI Pharmaceuticals Announces FDA Approval and Launch of Isosorbide Mononitrate Tablet
NDA FilingapprovedIsosorbide Mononitrate Tablet USPPositive
AI Analysis
Summary
ANI Pharmaceuticals received FDA approval for its ANDA and launched Isosorbide Mononitrate Tablet USP (10 mg and 20 mg), a generic version of Monoket. The drug is now commercially available.
Outcome Details
FDA approval of ANDA for Isosorbide Mononitrate Tablet USP 10 mg and 20 mg; generic version of Monoket
Importance:6/10
Sentiment:
0.70
FDA approvalgeneric drugANDAlaunchcardiovascular
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Published by GlobeNewswire Pharma on April 8, 2026 10:50 AM