Bijuva

NDA 210132, held by Mayne Pharma. Estradiol; Progesterone.

As of Nov 14, 2026, NDA 210132 (Bijuva), held by Mayne Pharma, was first approved by FDA on Oct 28, 2018, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2018
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


Dec 28, 2021	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 28, 2018	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Bijuva1MG;100MG · capsule;oral	Estradiol; Progesterone	RxReference drug
Bijuva0.5MG;100MG · capsule;oral	Estradiol; Progesterone	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Feb 12, 2026	Supplement 13Labeling · Standard review	Approved	Label Letter
Feb 15, 2024	Supplement 11Labeling · Standard review	Approved	Label Letter
Dec 28, 2021	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 22, 2021	Supplement 3Labeling · Standard review	Approved	Label Letter
Jun 22, 2021	Supplement 1Labeling · Standard review	Approved	Label Letter
Oct 28, 2018	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 210132
Drugs@FDA: Overview at FDA
Company: Mayne Pharma

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