The U.S. Food and Drug Administration has issued an approval (status AP) for application ANDA078441 submitted by IMPAX LABS. The approval covers oral tablet products of the active ingredient ACARBOSE, marketed as prescription drugs.
Three dosage strengths are approved: 25 mg, 50 mg, and 100 mg tablets. All products are designated as non‑reference (generic) drugs and are intended for oral administration.
法规动态2026年9月9日•3 分钟阅读
FDA Approves IMPAX Labs' ACARBOSE Oral Tablets (ANDA 078441)
FDA granted approval for IMPAX Labs' ANDA 078441, authorizing prescription oral tablets of ACARBOSE in 25 mg, 50 mg, and 100 mg strengths.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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