Hetero Labs LTD III

AUG 25, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metoprolol Succinate (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling changes to an existing metoprolol succinate extended-release tablet formulation; this is a regulatory action record, not a clinical evidence evaluation.

JUN 30, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Naproxen (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for naproxen labeling changes; does not report clinical trial outcomes or comparative efficacy data.

MAR 12, 2026 · REGULATORY APPROVAL

FDA approval: Promethazine Hydrochloride AND Dextromethorphan Hydrobromide

U.S. Food and Drug Administration

FDA approval of a fixed-dose combination syrup; this is a regulatory action confirming manufacturing and quality standards, not a clinical efficacy determination.