Epzicom

NDA 21652, held by Viiv Hlthcare. Abacavir Sulfate; Lamivudine.

As of Nov 14, 2026, NDA 21652 (Epzicom), held by Viiv Hlthcare, was first approved by FDA on Aug 2, 2004, with 17 approved supplements and 0 published complete response letters.

First approved: Aug 2, 2004
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

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


Dec 10, 2021	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Sep 17, 2015	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review Pediatric Statistical Review
Aug 2, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
EpzicomEQ 600MG BASE;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Abacavir Sulfate; Lamivudine	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Dec 10, 2021	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Feb 17, 2021	Supplement 28Labeling · Standard review	Approved	Label Letter
May 10, 2019	Supplement 24Labeling · Standard review	Approved	Letter Label
Apr 27, 2018	Supplement 23Labeling · Standard review	Approved	Label Letter
Mar 20, 2017	Supplement 22Labeling · Standard review	Approved	Letter Label
Sep 29, 2015	Supplement 21Labeling · Standard review	Approved	Label Letter
Sep 17, 2015	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review Pediatric Statistical Review
Feb 19, 2015	Supplement 18Labeling · Standard review	Approved	Letter Label
May 18, 2012	Supplement 16Labeling · Standard review	Approved	Letter Label
Mar 12, 2012	Supplement 15Labeling · Standard review	Approved	Letter Label
Nov 18, 2011	Supplement 14Labeling	Approved	Label Letter
May 13, 2011	Supplement 13REMS	Approved	Letter
Feb 2, 2011	Supplement 10Labeling · Standard review	Approved	Letter Label
Aug 4, 2010	Supplement 11REMS	Approved	Letter
Mar 9, 2009	Supplement 8Labeling · Standard review	Approved	Label Letter
May 7, 2007	Supplement 5Labeling · Standard review	Approved	Letter Label
Aug 11, 2006	Supplement 3Labeling · Standard review	Approved	Letter Label
Aug 2, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21652
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