FDA Approves ANDA077302 for Actavis Extended‑Release Amphetamine Combination Capsules

The U.S. Food and Drug Administration has approved abbreviated new drug application (ANDA) number 077302 submitted by Actavis Pharma, Inc. The approval covers a prescription, oral, extended‑release capsule formulation that combines four active ingredients: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate. The product is listed under the generic name comprising these four salts and is available in four strength levels, each capsule containing 1.25 mg, 3.75 mg, 6.25 mg, or 7.5 mg of each active ingredient. Corresponding National Drug Code (NDC) identifiers include 0228‑3059‑11, 0228‑3060‑11, 0228‑3062‑11, among others. The capsules are designated for prescription use only. This approval introduces a generic extended‑release amphetamine combination to the market, expanding the range of available prescription options.