FDA Grants ANDA Approval for Atomoxetine Capsules by Strides Pharma

The U.S. Food and Drug Administration has issued an approval for application number ANDA079021, authorizing the marketing of atomoxetine hydrochloride oral capsules produced by Strides Pharma Science Limited. The approved products are prescription‑only, oral capsules available in multiple strengths: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg base equivalents. Each product is identified by a specific product number and corresponding package NDC codes. The approval confirms that these generic formulations meet the FDA’s standards for safety, efficacy, and quality, providing an additional treatment option for conditions managed with atomoxetine. The approval includes a range of capsule strengths to support flexible dosing, and all products are classified under the human prescription drug category. This regulatory decision expands the availability of generic atomoxetine in the U.S. market.