← FDA DRUG APPROVALS

FDA NDA · NDA200327

TEFLARO

ceftaroline fosamil

Sponsor: ABBVIE

APPLICATION
NDA200327
TYPE
NDA
ORIGINAL APPROVAL
2010-10-29
LATEST ACTION
2021-12-02
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

TEFLARO · ReferencePrescription
CEFTAROLINE FOSAMIL 600MG/VIAL · POWDER · INTRAVENOUS
TEFLARO · ReferencePrescription
CEFTAROLINE FOSAMIL 400MG/VIAL · POWDER · INTRAVENOUS

Approval history

2021-12-02Labeling · Supplement 28 · standard — Label ↗AP
2020-11-27Labeling · Supplement 25 · standard — Label ↗AP
2019-09-13Efficacy · Supplement 22 · standard — Letter ↗AP
2016-05-27Efficacy · Supplement 16 · priority — Label ↗AP
2016-05-27Efficacy · Supplement 17 · priority — Pediatric Medical Review ↗AP
2015-08-31Efficacy · Supplement 14 · standard — Label ↗AP
2015-08-31Labeling · Supplement 15 · standard — Letter ↗AP
2015-08-31Efficacy · Supplement 13 · standard — Letter ↗AP
2014-02-28Manufacturing (CMC) · Supplement 12 · standardAP
2013-12-16Labeling · Supplement 11 · standard — Label ↗AP
2013-07-29Manufacturing (CMC) · Supplement 10 · standard — Label ↗AP
2013-05-29Labeling · Supplement 9 · standard — Label ↗AP
2012-10-23Labeling · Supplement 8 · standard — Letter ↗AP
2012-05-22Labeling · Supplement 5 · standard — Pediatric Other ↗AP
2012-05-03Manufacturing (CMC) · Supplement 7 — Label ↗AP
2011-06-29Labeling · Supplement 1 · unknown — Letter ↗AP
2011-03-11Labeling · Supplement 3 · standard — Letter ↗AP
2010-10-29Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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