← FDA DRUG APPROVALS

FDA NDA · NDA050748

SYNERCID

Sponsor: KING PHARMS

APPLICATION
NDA050748
TYPE
NDA
ORIGINAL APPROVAL
1999-09-21
LATEST ACTION
2017-06-16
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

SYNERCID · ReferenceDiscontinued
DALFOPRISTIN 350MG/VIAL, QUINUPRISTIN 150MG/VIAL · INJECTABLE · INTRAVENOUS
SYNERCIDDiscontinued
DALFOPRISTIN 420MG/VIAL, QUINUPRISTIN 180MG/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2017-06-16Labeling · Supplement 14 · standard — Label ↗AP
2012-01-13Labeling · Supplement 13 · standard — Label ↗AP
2010-11-12Labeling · Supplement 10 · standard — Label ↗AP
2010-11-12Labeling · Supplement 9 · standard — Label ↗AP
2008-06-18Labeling · Supplement 8 · standard — Letter ↗AP
2002-12-26Manufacturing (CMC) · Supplement 4 · standardAP
2002-12-26Manufacturing (CMC) · Supplement 3 · standardAP
2000-08-24Manufacturing (CMC) · Supplement 2 · standardAP
2000-07-13Labeling · Supplement 1 · standardAP
1999-09-21Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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