Regulatory UpdatesSep 12, 2026•1 min read

FDA Approves ANDA216216 for METOLAZONE Tablets

By the PharmaCountry team

The FDA has approved application ANDA216216 for METOLAZONE oral tablets in 2.5 mg, 5 mg, and 10 mg strengths, sponsored by NE RX Pharma.

On October 25, 2022, the U.S. Food and Drug Administration (FDA) issued an approval (status AP) for application number ANDA216216. The approved product is METOLAZONE, an oral thiazide‑like diuretic, marketed as prescription tablets in three strengths: 2.5 mg, 5 mg, and 10 mg. The sponsor listed for the ANDA is NE RX Pharma. The tablets are manufactured by Aarkish Pharmaceuticals NJ Inc. and Marlex Pharmaceuticals, Inc. The submission was classified as a standard original (ORIG) application and received standard review priority.

Compiled by the PharmaCountry team · Source: FDA.gov