Imvexxy

NDA 208564, held by Mayne Pharma. Estradiol.

As of Nov 14, 2026, NDA 208564 (Imvexxy), held by Mayne Pharma, was first approved by FDA on May 29, 2018, with 3 approved supplements and 1 published complete response letter.

First approved: May 29, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 1

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 29, 2018	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
May 5, 2017	EstradiolClinical Safety	Approved

Products

2 strengths and forms


Imvexxy0.004MG · insert;vaginal	Estradiol	RxReference drug
Imvexxy0.01MG · insert;vaginal	Estradiol	RxReference drug

All 4 submissions, including labeling and manufacturing supplements


Feb 15, 2024	Supplement 6Labeling · Standard review	Approved	Label Letter
Nov 16, 2021	Supplement 2Labeling · Standard review	Approved	Letter Label
Nov 21, 2019	Supplement 3Labeling · Standard review	Approved	Label Letter
May 29, 2018	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 208564
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