Blisovi 24 Fe

ANDA 91398, held by Lupin. Ethinyl Estradiol; Norethindrone Acetate.

As of Nov 15, 2026, ANDA 91398 (Blisovi 24 Fe), held by Lupin, was first approved by FDA on Oct 28, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2015
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Blisovi 24 Fe is indicated for use by women to prevent pregnancy. The efficacy of Blisovi 24 Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 28, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Blisovi 24 Fe0.02MG;1MG · tablet;oral	Ethinyl Estradiol; Norethindrone Acetate	Rx

All 8 submissions, including labeling and manufacturing supplements


Jun 18, 2025	Supplement 22Labeling · Standard review	Approved	None posted
Jun 18, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Apr 29, 2022	Supplement 20Labeling · Standard review	Approved	None posted
Nov 15, 2019	Supplement 14Manufacturing	Approved	None posted
May 1, 2019	Supplement 1Labeling · Standard review	Approved	None posted
May 1, 2019	Supplement 5Labeling · Standard review	Approved	None posted
May 1, 2019	Supplement 9Manufacturing	Approved	None posted
Oct 28, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 91398
Drugs@FDA: Overview at FDA
Company: Lupin

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters