Levitra

NDA 21400, held by Bayer Hlthcare. Vardenafil Hydrochloride.

As of Nov 14, 2026, NDA 21400 (Levitra), held by Bayer Hlthcare, was first approved by FDA on Aug 19, 2003, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 19, 2003
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Aug 2, 2013	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 19, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


LevitraEQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Vardenafil Hydrochloride	DiscontinuedReference drug
LevitraEQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Vardenafil Hydrochloride	DiscontinuedReference drug
LevitraEQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Vardenafil Hydrochloride	DiscontinuedReference drug
LevitraEQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Vardenafil Hydrochloride	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Mar 15, 2023	Supplement 23Labeling · Standard review	Approved	Label
Aug 16, 2017	Supplement 20Labeling · Standard review	Approved	Letter Label
Sep 16, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
Nov 3, 2014	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 29, 2014	Supplement 17Labeling · Standard review	Approved	Label Letter
Aug 2, 2013	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 22, 2011	Supplement 13Labeling · Standard review	Approved	Label Letter
May 15, 2008	Supplement 12Labeling · Standard review	Approved	Letter
Mar 19, 2008	Supplement 11Labeling · Standard review	Approved	Letter Label
Oct 18, 2007	Supplement 10Labeling · Standard review	Approved	Letter Label
Apr 6, 2007	Supplement 8Labeling · Standard review	Approved	Letter Label
Jul 8, 2005	Supplement 4Labeling · Standard review	Approved	Letter Label
May 13, 2005	Supplement 2Labeling · Standard review	Approved	Label Letter
Aug 19, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21400
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

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