Zagam

NDA 20677, held by Mylan. Sparfloxacin.

As of Nov 13, 2026, NDA 20677 (Zagam), held by Mylan, was first approved by FDA on Dec 19, 1996, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 19, 1996
Review: Standard
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 19, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zagam200MG · tablet;oral	Sparfloxacin	Discontinued

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 4, 2003	Supplement 6Labeling · Standard review	Approved	Letter Label
Oct 2, 2002	Supplement 4Labeling · Standard review	Approved	Letter Label
May 11, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 10, 1999	Supplement 3Manufacturing · Standard review	Approved	Review
Oct 19, 1999	Supplement 1Labeling · Standard review	Approved	Review
Oct 19, 1999	Supplement 2Labeling · Standard review	Approved	Review
Dec 19, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20677
Drugs@FDA: Overview at FDA
Company: Mylan

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