Synercid

NDA 50747, held by King Pharms. Quinupristin; Dalfopristin.

As of Nov 14, 2026, NDA 50747 (Synercid), held by King Pharms, was first approved by FDA on Sep 21, 1999, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 21, 1999
Review: Priority
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Sep 21, 1999	Original applicationNew molecular entity · Priority review	Approved	Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Synercid500MG · injectable; injection	Quinupristin; Dalfopristin	Rx

All 9 submissions, including labeling and manufacturing supplements


Jun 16, 2017	Supplement 15Labeling · Standard review	Approved	Letter Label
Jan 13, 2012	Supplement 14Labeling · Standard review	Approved	Label Letter
Nov 12, 2010	Supplement 11Labeling · Standard review	Approved	Letter Label
Jun 18, 2008	Supplement 8Labeling · Standard review	Approved	Letter Label
Dec 26, 2002	Supplement 3Manufacturing · Priority review	Approved	None posted
Dec 26, 2002	Supplement 4Manufacturing · Priority review	Approved	None posted
Mar 13, 2002	Supplement 2Labeling · Standard review	Approved	None posted
Aug 24, 2000	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 21, 1999	Original applicationNew molecular entity · Priority review	Approved	Letter Label

Identifiers

Application: NDA 50747
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