FDA Approves ORSYTHIA (ANDA077099) Oral Tablet

The U.S. Food and Drug Administration has granted approval (status AP) for ANDA 077099, associated with the oral tablet product ORSYTHIA. The product is formulated as a 28‑day oral tablet containing 0.02 mg ethinyl estradiol and 0.1 mg levonorgestrel. ORSYTHIA is listed as discontinued in the FDA database. The sponsor for this application is PH Health. The approval follows a series of submissions: an original submission (ORIG 1) approved on 11 May 2011; multiple labeling submissions (SUPPL 7 approved 9 Aug 2017, SUPPL 8 approved 29 Apr 2022) and manufacturing CMC submissions (SUPPL 1 approved 3 Jan 2012, SUPPL 5 approved 30 Apr 2014). All submissions received standard review priority unless otherwise noted.