Regulatory UpdatesSep 10, 2026•1 min read

FDA Approves ANDA 076335 for TRI-PREVIFEM Oral Tablet

By the PharmaCountry team

The FDA approved ANDA 076335 for the oral tablet TRI-PREVIFEM, containing ethinyl estradiol and norgestimate, sponsored by PH HEALTH. The product is listed as discontinued.

The U.S. Food and Drug Administration has granted approval for ANDA 076335, which corresponds to the oral tablet product TRI‑PREVIFEM. TRI‑PREVIFEM is an oral tablet (route ORAL‑28) that contains the active ingredients ethinyl estradiol (0.035 mg) and norgestimate (available in strengths of 0.18 mg, 0.215 mg, and 0.25 mg). The product is marked as discontinued and was submitted by sponsor PH HEALTH. The submission history includes an original approval package filed on 26 Mar 2004 (submission 1). Subsequent labeling submissions were approved on 3 Jan 2013 (submission 14), 19 Dec 2014 (submission 17), 24 Jun 2016 (submission 16), 24 Jun 2016 (submission 19), 3 Feb 2022 (submission 20), and 29 Apr 2022 (submission 21). A manufacturing (CMC) submission (submission 16) received approval on 24 Jun 2016. All listed submissions have an approved status.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA #oral contraceptive #ethinyl estradiol #norgestimate #pharmaceutical regulation