Retrovir

Treats Human Immunodeficiency Virus (HIV-1) infection. NDA 19655, held by Viiv Hlthcare. Zidovudine.

As of Nov 14, 2026, NDA 19655 (Retrovir), held by Viiv Hlthcare, was first approved by FDA on Mar 19, 1987, with 42 approved supplements and 0 published complete response letters.

First approved: Mar 19, 1987
Review: Priority
Supplements approved: 42
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

RETROVIR is a nucleoside analogue reverse transcriptase inhibitor indicated for:

Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents.
Prevention of maternal-fetal HIV-1 transmission. 1.1 Treatment of HIV-1 RETROVIR, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 1.2 Prevention of Maternal-Fetal HIV-1 Transmission RETROVIR is indicated for the prevention of maternal-fetal HIV-1 transmission. The indication is based on a dosing regimen that included 3 components: 1. antepartum therapy of HIV‑1–infected mothers 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 43 submissions below


Sep 19, 2008	Supplement 46Efficacy (new indication or use)	Approved	Label Letter
Oct 4, 1996	Supplement 29Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 4, 1996	Supplement 26Efficacy (new indication or use)	Approved	None posted
Aug 8, 1994	Supplement 23Efficacy (new indication or use) · Priority review	Approved	None posted
Jan 12, 1990	Supplement 13Efficacy (new indication or use)	Approved	None posted
Mar 19, 1987	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Retrovir100MG · capsule;oral	Zidovudine	RxReference drug

All 43 submissions, including labeling and manufacturing supplements


Dec 18, 2024	Supplement 60Labeling · Standard review	Approved	Label Letter
Jun 18, 2020	Supplement 59Labeling · Standard review	Approved	Label Letter
Sep 10, 2018	Supplement 58Labeling · Standard review	Approved	Letter Label
Nov 28, 2017	Supplement 57Labeling · Standard review	Approved	Letter Label
Apr 10, 2017	Supplement 56Labeling · Standard review	Approved	Letter Label
Feb 24, 2017	Supplement 55Labeling · Standard review	Approved	Letter Label
Dec 23, 2014	Supplement 54Labeling · Standard review	Approved	Label Letter
May 31, 2012	Supplement 53Labeling · Standard review	Approved	Label Letter
Nov 18, 2011	Supplement 52Labeling	Approved	Letter Label
May 17, 2010	Supplement 49Labeling · Standard review	Approved	Letter Label
Nov 6, 2009	Supplement 48Labeling · Standard review	Approved	Letter Label
Sep 19, 2008	Supplement 46Efficacy (new indication or use)	Approved	Label Letter
Nov 15, 2006	Supplement 43Labeling · Standard review	Approved	Letter Label
May 10, 2006	Supplement 41Labeling · Standard review	Approved	Letter Label
Oct 15, 2003	Supplement 39Labeling · Standard review	Approved	Letter Label
Dec 18, 2002	Supplement 38Labeling · Standard review	Approved	Label Letter
Feb 21, 2002	Supplement 37Labeling · Standard review	Approved	Letter
Oct 5, 2001	Supplement 36Labeling · Standard review	Approved	Label
Mar 30, 2001	Supplement 32Labeling · Standard review	Approved	Review Letter Label
Feb 1, 2000	Supplement 35Manufacturing	Approved	None posted
Feb 26, 1999	Supplement 34Manufacturing	Approved	None posted
Dec 28, 1998	Supplement 33Manufacturing	Approved	None posted
Mar 4, 1998	Supplement 30Labeling · Standard review	Approved	None posted
Nov 4, 1997	Supplement 31Manufacturing	Approved	None posted
Oct 4, 1996	Supplement 29Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 4, 1996	Supplement 26Efficacy (new indication or use)	Approved	None posted
Jul 20, 1995	Supplement 27Labeling · Standard review	Approved	None posted
Feb 6, 1995	Supplement 25Manufacturing	Approved	None posted
Oct 7, 1994	Supplement 24Labeling · Standard review	Approved	None posted
Aug 8, 1994	Supplement 23Efficacy (new indication or use) · Priority review	Approved	None posted
Aug 8, 1994	Supplement 20Labeling	Approved	None posted
Aug 24, 1993	Supplement 22Labeling · Standard review	Approved	None posted
Aug 24, 1993	Supplement 12Labeling	Approved	None posted
Aug 24, 1993	Supplement 3Labeling	Approved	None posted
May 2, 1990	Supplement 15Labeling	Approved	None posted
Apr 30, 1990	Supplement 14Manufacturing	Approved	None posted
Mar 2, 1990	Supplement 11Labeling	Approved	None posted
Jan 12, 1990	Supplement 13Efficacy (new indication or use)	Approved	None posted
Mar 13, 1989	Supplement 9Manufacturing	Approved	None posted
Mar 6, 1989	Supplement 8Manufacturing	Approved	None posted
Oct 13, 1988	Supplement 5Manufacturing	Approved	None posted
Apr 21, 1987	Supplement 1Manufacturing	Approved	None posted
Mar 19, 1987	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19655
Drugs@FDA: Overview at FDA
Company: ViiV 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