FDA Approves Zydus Pharms Indomethacin Extended‑Release Capsule (ANDA202711)

The U.S. Food and Drug Administration has granted approval for ANDA202711, an abbreviated new drug application submitted by Zydus Pharms. The approved product is an oral, extended‑release capsule containing 75 mg of indomethacin, marketed as a prescription medication. The application’s submission record shows an original filing in 2017 (letter dated September 29, 2017), followed by labeling supplement submissions approved on September 18, 2019, April 28, 2021, and most recently November 21, 2024. All submissions were reviewed under standard priority and received an “AP” (approved) status.