Synercid

NDA 50748, held by King Pharms. Dalfopristin; Quinupristin.

As of Nov 13, 2026, NDA 50748 (Synercid), held by King Pharms, was first approved by FDA on Sep 21, 1999, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 21, 1999
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Sep 21, 1999	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Synercid350MG/VIAL;150MG/VIAL · injectable;intravenous	Dalfopristin; Quinupristin	DiscontinuedReference drug
Synercid420MG/VIAL;180MG/VIAL · injectable;intravenous	Dalfopristin; Quinupristin	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jun 16, 2017	Supplement 14Labeling · Standard review	Approved	Letter Label
Jan 13, 2012	Supplement 13Labeling · Standard review	Approved	Label Letter
Nov 12, 2010	Supplement 9Labeling · Standard review	Approved	Letter Label
Nov 12, 2010	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 18, 2008	Supplement 8Labeling · Standard review	Approved	Letter Label
Dec 26, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 26, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 24, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 13, 2000	Supplement 1Labeling · Standard review	Approved	None posted
Sep 21, 1999	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 50748
Drugs@FDA: Overview at FDA
Company: King 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