FDA Updates LOESTRIN 21 1.5/30 (NDA 017875) Submissions

LOESTRIN 21 1.5/30 is an oral tablet (route ORAL-21) containing 0.03 mg ethinyl estradiol and 1.5 mg norethindrone acetate. The product is listed as a reference drug and its marketing status is marked as discontinued. The FDA submission history for NDA 017875 includes numerous standard‑priority submissions. Early manufacturing (CMC) submissions were filed on 28 July 1997 (submission 26) and 7 July 1995 (submission 24). Labeling submissions span from 8 March 1996 (submission 18) through 24 November 1999 (submission 30) and 2 May 2003 (submission 32). Additional manufacturing submissions were recorded on 16 May 1989 (submission 16) and 26 May 2014 (submission 34). The most recent activity is submission 40, approved on 29 April 2022, which includes a labeling letter (02 May 2022) and the final label (04 May 2022) for the product. All submissions are marked as approved (status "AP").