The U.S. Food and Drug Administration (FDA) has approved labeling for a generic itraconazole oral capsule submitted by Jubilant Generics under application number ANDA203445.
The product, identified as ITRACONAZOLE 100 MG capsule, is marked with a discontinued marketing status and is not a reference listed drug.
The original submission (submission 1) received approval on 23 Feb 2017, and subsequent labeling supplements (submissions 1, 2, and 5) were approved on 25 Oct 2019.
法规动态2026年9月16日•3 分钟阅读
FDA Approves Jubilant Itraconazole 100 mg Capsule (ANDA203445)
FDA approved labeling for Jubilant Generics' oral itraconazole 100 mg capsule (ANDA203445); the product is listed as discontinued.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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