Retrovir

Treats Human Immunodeficiency Virus (HIV-1) infection. NDA 19951, held by Viiv Hlthcare. Zidovudine.

As of Nov 13, 2026, NDA 19951 (Retrovir), held by Viiv Hlthcare, was first approved by FDA on Feb 2, 1990, with 30 approved supplements and 0 published complete response letters.

First approved: Feb 2, 1990
Review: Priority
Supplements approved: 30
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 31 submissions below


Aug 8, 1994	Supplement 3Efficacy (new indication or use) · Priority review	Approved	None posted
Feb 2, 1990	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Retrovir10MG/ML · injectable;injection	Zidovudine	RxReference drug

All 31 submissions, including labeling and manufacturing supplements


Nov 11, 2024	Supplement 39Manufacturing	Approved	Label Letter
Nov 11, 2024	Supplement 38Manufacturing	Approved	None posted
Jun 18, 2020	Supplement 37Labeling · Standard review	Approved	Label Letter
Sep 10, 2018	Supplement 36Labeling · Standard review	Approved	Letter Label
Nov 28, 2017	Supplement 35Labeling · Standard review	Approved	Letter Label
Apr 10, 2017	Supplement 34Labeling · Standard review	Approved	Letter Label
Feb 24, 2017	Supplement 33Labeling · Standard review	Approved	Letter Label
Dec 23, 2014	Supplement 32Labeling · Standard review	Approved	Label Letter
Dec 19, 2013	Supplement 31Manufacturing	Approved	None posted
May 31, 2012	Supplement 30Labeling · Standard review	Approved	Label Letter
Nov 18, 2011	Supplement 29Labeling	Approved	Letter Label
Nov 15, 2006	Supplement 24Labeling · Standard review	Approved	Letter
Jul 10, 2006	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 29, 2003	Supplement 19Labeling · Standard review	Approved	Letter Label
Jul 25, 2003	Supplement 18Labeling · Standard review	Approved	Letter Label
Aug 19, 2002	Supplement 20Manufacturing	Approved	None posted
Feb 21, 2002	Supplement 17Labeling · Standard review	Approved	Letter
Sep 12, 2001	Supplement 16Labeling · Standard review	Approved	Label
Feb 1, 2000	Supplement 15Manufacturing	Approved	None posted
Feb 26, 1999	Supplement 14Manufacturing	Approved	None posted
Mar 4, 1998	Supplement 12Labeling · Standard review	Approved	None posted
Feb 12, 1998	Supplement 10Labeling · Standard review	Approved	None posted
Aug 18, 1997	Supplement 11Manufacturing	Approved	None posted
Apr 2, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Mar 22, 1996	Supplement 8Labeling	Approved	None posted
Jul 20, 1995	Supplement 7Labeling · Standard review	Approved	None posted
Feb 6, 1995	Supplement 5Manufacturing	Approved	None posted
Oct 7, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Aug 8, 1994	Supplement 3Efficacy (new indication or use) · Priority review	Approved	None posted
Aug 7, 1992	Supplement 1Manufacturing	Approved	None posted
Feb 2, 1990	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 19951
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