Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA210596 for VYDUO Oral Tablet (Nebivolol/Valsartan)
The FDA has approved ANDA210596 for VYDUO, an oral tablet combining nebivolol hydrochloride (5 mg) and valsartan (80 mg), submitted by Prinston Inc.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Records Submissions for Teva’s Discontinued Amlodipine/Valsartan/HCTZ Tablets (ANDA 200435)
FDA records multiple labeling submissions for Teva’s discontinued oral tablet combining amlodipine besylate, valsartan, and hydrochlorothiazide (ANDA 200435). All listed product variants are marked discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Ohm Laboratories’ Generic Valsartan (ANDA 077492)
The FDA has granted approval for Ohm Laboratories’ generic Valsartan tablets (40‑320 mg) under application ANDA 077492.