FDA Approves Labeling for Norethindrone/Ethinyl Estradiol Tablet (ANDA078379)

The Food and Drug Administration (FDA) has approved labeling submissions for an oral tablet product containing norethindrone 0.4 mg and ethinyl estradiol 0.035 mg. The product, listed under the brand name "NORETHINDRONE AND ETHINYL ESTRADIOL," is administered via the oral route (ORAL-21) and is classified as a tablet. The application, identified as ANDA078379, was submitted by Watson Labs. The original submission (submission number 1) received approval on February 23, 2010. Subsequent labeling submissions (submission numbers 5 and 6) were approved on August 9, 2017, and April 29, 2022, respectively. The product’s marketing status is noted as discontinued. Key details: - Active ingredients: norethindrone 0.4 mg, ethinyl estradiol 0.035 mg - Dosage form: tablet - Route: oral - Sponsor: Watson Labs - Application number: ANDA078379 - Submission history: original approval 2010; labeling approvals 2017 and 2022 - Marketing status: discontinued