FDA Approves ANDA078670 for Pioglitazone Hydrochloride Tablets

The U.S. Food and Drug Administration has granted approval for ANDA078670, an abbreviated new drug application submitted by Aiping Pharm Inc. The approved products are oral tablet formulations of pioglitazone hydrochloride, marketed as prescription drugs, available in three strengths: 15 mg (product number 001), 30 mg (product number 002), and 45 mg (product number 003) based on equivalent base content. The application includes multiple supplemental submissions (numbers 2, 4, and 5) classified as labeling updates, all reviewed with standard priority and receiving approval on dates ranging from 2013‑02‑13 to 2019‑01‑14. No reference drug or reference standard was cited for these products, and they are not identified as reference listed drugs.