Abacavir Sulfate

Treats human immunodeficiency virus (HIV-1) infection. ANDA 91294, held by Mylan Pharms Inc. Abacavir Sulfate.

As of Nov 15, 2026, ANDA 91294 (Abacavir Sulfate), held by Mylan Pharms Inc, was first approved by FDA on Jun 18, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 18, 2012
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 18, 2012	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Abacavir SulfateEQ 300MG BASE · tablet;oral	Abacavir Sulfate	Rx

All 5 submissions, including labeling and manufacturing supplements


Apr 25, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 3Manufacturing	Approved	None posted
Dec 11, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Jun 18, 2012	Original application	Approved	Review Letter

Identifiers

Application: ANDA 91294
Drugs@FDA: Overview at FDA
Company: Mylan Pharmaceuticals

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