The U.S. Food and Drug Administration (FDA) has granted an Abbreviated New Drug Application (ANDA) approval for Voriconazole injection, identified by application number ANDA220043.
The product, marketed under the brand name Voriconazole, is an intravenous solution containing 200 mg per 20 mL (10 mg/mL) of the antifungal agent. It is classified as a prescription human drug.
The sponsor listed is Hainan Poly Pharm, with manufacturing also attributed to PAI Holdings, LLC dba PAI Pharma. The submission included labeling (submission type SUPPL) approved on May 29, 2026, and an original application letter dated November 18, 2025, with overall approval status recorded on November 14, 2025.
FDA records list the product’s NDC codes 0121‑1091‑55 and 14335‑730‑10, and indicate its pharmacologic class as an azole antifungal and cytochrome P450 inhibitor.
法规动态2026年9月18日•3 分钟阅读
FDA Grants ANDA Approval for Voriconazole Injection (ANDA220043)
The FDA approved an ANDA for Voriconazole injection, a 10 mg/mL intravenous antifungal solution, sponsored by Hainan Poly Pharm.
由 Pharmacountry 团队整理 · 来源： FDA.gov
主题：
评分
(0)
(0)
(0)
(0)
(0)
留下您的评分