FDA approves ANDA090609 for atomoxetine capsules by Dr. Reddy's Laboratories

The U.S. Food and Drug Administration has approved abbreviated new drug application (ANDA) number ANDA090609 submitted by Dr. Reddy's Laboratories Limited. The approval pertains to atomoxetine hydrochloride oral capsules marketed under the brand name ATOMOXETINE. The authorized products are prescription‑only capsules available in strengths of 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg base equivalents. Each strength is associated with specific National Drug Code (NDC) identifiers, for example 55111‑519‑30 (10 mg) and 55111‑520‑30 (100 mg). All formulations are intended for oral administration. These capsules are classified as human prescription drugs and expand the generic atomoxetine market, offering additional dosage options for healthcare providers and patients.