The U.S. Food and Drug Administration (FDA) issued an approval letter for application ANDA210596 on September 19, 2022. The approved product is VYDUO, an oral tablet intended for prescription use.
VYDUO contains two active ingredients: nebivolol hydrochloride (equivalent to 5 mg base) and valsartan 80 mg. The dosage form is a tablet administered orally. The product is not a reference drug and does not rely on a reference standard.
The submission was made by Prinston Inc. as an original (ORIG) application with standard review priority. The submission status is listed as "AP" (approved). The FDA’s approval letter, dated November 28, 2022, is available at the FDA’s website.
This approval adds VYDUO to the market as a prescription‑only medication for its indicated therapeutic use.
法规动态2026年9月18日•3 分钟阅读
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.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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