Viracept

Treats HIV-1 infection. NDA 21503, held by Agouron Pharms. Nelfinavir Mesylate.

As of Nov 13, 2026, NDA 21503 (Viracept), held by Agouron Pharms, was first approved by FDA on Apr 30, 2003, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2003
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. VIRACEPT is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Mar 19, 2004	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Apr 30, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
ViraceptEQ 625MG BASE · tablet;oral	Nelfinavir Mesylate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 24, 2021	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 15, 2016	Supplement 24Labeling	Approved	Letter Label
Mar 27, 2015	Supplement 23Labeling	Approved	Label Letter
May 28, 2013	Supplement 21Labeling · Standard review	Approved	Label Letter
Apr 6, 2012	Supplement 18Labeling · Standard review	Approved	Letter Label
Feb 17, 2012	Supplement 20Labeling	Approved	Letter Label
Feb 25, 2011	Supplement 17Labeling · Standard review	Approved	Label Letter
Apr 26, 2010	Supplement 16Labeling	Approved	Label Letter
Apr 26, 2010	Supplement 15Labeling	Approved	Label Letter
Nov 25, 2008	Supplement 14Labeling · Standard review	Approved	Letter
Feb 13, 2008	Supplement 11Labeling · Standard review	Approved	Label Letter
Jul 31, 2007	Supplement 9Labeling · Standard review	Approved	Label
Dec 22, 2006	Supplement 7Labeling · Standard review	Approved	Letter Label
Sep 28, 2005	Supplement 6Labeling · Standard review	Approved	Review Letter Label
Jun 4, 2004	Supplement 3Labeling · Standard review	Approved	Letter Label
Mar 19, 2004	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Aug 27, 2003	Supplement 2Labeling · Standard review	Approved	Letter Label
Apr 30, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21503
Drugs@FDA: Overview at FDA
Company: Agouron Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters