FDA Approves Teva Generic Olanzapine (ANDA 077243)

The U.S. Food and Drug Administration (FDA) granted approval for Teva Pharmaceuticals USA, Inc.’s generic olanzapine tablets under application number ANDA077243. The product is marketed as a prescription oral tablet, available in four strengths: 5 mg, 10 mg, 15 mg, and 20 mg, each in an orally disintegrating tablet form. The original submission (submission number 1) was filed on November 14, 2006 and received an approval status on January 30, 2012. Since then, Teva has submitted multiple supplemental applications (submission numbers 1, 3, 5, and 7) focused on labeling updates, with the most recent labeling supplement approved on November 16, 2020. Olanzapine is classified as an atypical antipsychotic and is listed under the FDA’s human prescription drug category. The product carries the National Drug Code (NDC) series 0093‑5245 to 0093‑5248 and is identified by the FDA’s unique ingredient identifier (UNII) N7U69T4SZR.