Biaxin Xl

NDA 50697, held by Abbvie Inc. Clarithromycin.

As of Nov 14, 2026, NDA 50697 (Biaxin Xl), held by Abbvie Inc, was first approved by FDA on Dec 23, 1993, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1993
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


May 24, 2002	Supplement 2Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 23, 1993	Original applicationTYPE 6 · Standard review	Approved	None posted

Products

2 strengths and forms


Biaxin Xl250MG · tablet;oral	Clarithromycin	Discontinued
Biaxin Xl500MG · tablet;oral	Clarithromycin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jul 19, 2004	Supplement 3Labeling · Standard review	Approved	Letter
May 24, 2002	Supplement 2Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 23, 1993	Original applicationTYPE 6 · Standard review	Approved	None posted

Identifiers

Application: NDA 50697
Drugs@FDA: Overview at FDA
Company: AbbVie

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