Teveten

NDA 20738, held by Abbvie. Eprosartan Mesylate.

As of Nov 13, 2026, NDA 20738 (Teveten), held by Abbvie, was first approved by FDA on Dec 22, 1997, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1997
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Oct 28, 1998	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Dec 22, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Products

3 strengths and forms


TevetenEQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Eprosartan Mesylate	Discontinued
TevetenEQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Eprosartan Mesylate	DiscontinuedReference drug
TevetenEQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Eprosartan Mesylate	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Jul 22, 2014	Supplement 29Labeling · Standard review	Approved	Letter Label
Sep 12, 2012	Supplement 28Labeling	Approved	Label Letter
Jan 19, 2012	Supplement 27Labeling	Approved	Label Letter
May 3, 2011	Supplement 26Labeling	Approved	Letter Label
Oct 16, 2003	Supplement 12Labeling · Standard review	Approved	Letter
Oct 29, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 15, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
May 8, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 2, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 5, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 4, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
May 27, 1999	Supplement 4Manufacturing · Standard review	Approved	Review
Oct 28, 1998	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Jun 30, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
May 21, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 22, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20738
Drugs@FDA: Overview at FDA
Company: AbbVie

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