FDA NDA · NDA050747

SYNERCID

Sponsor: KING PHARMS

APPLICATION

NDA050747

TYPE

NDA

ORIGINAL APPROVAL

1999-09-21

LATEST ACTION

2017-06-16

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

SYNERCIDPrescription

QUINUPRISTIN 500MG, DALFOPRISTIN · INJECTABLE · INJECTION

2017-06-16Labeling · Supplement 15 · standard — Label ↗AP

2012-01-13Labeling · Supplement 14 · standard — Label ↗AP

2010-11-12Labeling · Supplement 11 · standard — Label ↗AP

2008-06-18Labeling · Supplement 8 · standard — Label ↗AP

2002-12-26Manufacturing (CMC) · Supplement 4 · priorityAP

2002-12-26Manufacturing (CMC) · Supplement 3 · priorityAP

2002-03-13Labeling · Supplement 2 · standardAP

2000-08-24Manufacturing (CMC) · Supplement 1 · priorityAP

1999-09-21Type 1 - New Molecular Entity · Original · priority — Label ↗AP

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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