Abacavir Sulfate

ANDA 201570, held by Apotex Inc. Abacavir Sulfate.

As of Nov 15, 2026, ANDA 201570 (Abacavir Sulfate), held by Apotex Inc, was first approved by FDA on Dec 17, 2012, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 17, 2012
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 17, 2012	Original application	Approved	None posted

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements


Jan 13, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Jan 13, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Jan 26, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Jan 26, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Jan 26, 2016	Supplement 4Labeling · Standard review	Approved	None posted
May 31, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Dec 17, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201570
Drugs@FDA: Overview at FDA
Company: Apotex

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