Fyavolv

Treats Moderate. ANDA 204213, held by Lupin. Ethinyl Estradiol; Norethindrone Acetate.

As of Nov 15, 2026, ANDA 204213 (Fyavolv), held by Lupin, was first approved by FDA on Dec 10, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 10, 2015
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fyavolv is a combination of an estrogen and progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Prevention of Postmenopausal Osteoporosis 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 10, 2015	Original application	Approved	None posted

Products

2 strengths and forms


Fyavolv0.0025MG;0.5MG · tablet;oral	Ethinyl Estradiol; Norethindrone Acetate	Rx
Fyavolv0.005MG;1MG · tablet;oral	Ethinyl Estradiol; Norethindrone Acetate	Rx

All 3 submissions, including labeling and manufacturing supplements


Feb 16, 2024	Supplement 8Labeling · Standard review	Approved	None posted
May 6, 2021	Supplement 6Manufacturing	Approved	None posted
Dec 10, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 204213
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