FDA Approves IMPAX Labs' ACARBOSE Oral Tablets (ANDA 078441)

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.