Dynabac

NDA 50678, held by Lilly Res Labs. Dirithromycin.

As of Nov 13, 2026, NDA 50678 (Dynabac), held by Lilly Res Labs, was first approved by FDA on Jun 19, 1995, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 19, 1995
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Dec 19, 1997	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review
Jun 19, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dynabac250MG · tablet, delayed release;oral	Dirithromycin	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 2Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 7Labeling · Standard review	Approved	None posted
May 23, 2002	Supplement 10Labeling · Standard review	Approved	Letter
Apr 1, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 1, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 28, 1998	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 22, 1998	Supplement 5Labeling · Standard review	Approved	None posted
Jul 21, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 13, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 19, 1997	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review
Jun 19, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 50678
Drugs@FDA: Overview at FDA
Company: Lilly Res Labs

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