Teflaro

NDA 200327, held by Abbvie. Ceftaroline Fosamil.

As of Nov 13, 2026, NDA 200327 (Teflaro), held by Abbvie, was first approved by FDA on Oct 29, 2010, with 17 approved supplements and 0 published complete response letters.

First approved: Oct 29, 2010
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Sep 13, 2019	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review
May 27, 2016	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric CDTL Review
May 27, 2016	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric CDTL Review
Aug 31, 2015	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 31, 2015	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 29, 2010	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms

Product	Active ingredient	Marketing
Teflaro400MG/VIAL · powder;intravenous	Ceftaroline Fosamil	RxReference drug
Teflaro600MG/VIAL · powder;intravenous	Ceftaroline Fosamil	RxReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 2, 2021	Supplement 28Labeling · Standard review	Approved	Letter Label
Nov 27, 2020	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 13, 2019	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review
May 27, 2016	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric CDTL Review
May 27, 2016	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric CDTL Review
Aug 31, 2015	Supplement 15Labeling · Standard review	Approved	Letter Label
Aug 31, 2015	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 31, 2015	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter
Feb 28, 2014	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 16, 2013	Supplement 11Labeling · Standard review	Approved	Label Letter
Jul 29, 2013	Supplement 10Manufacturing · Standard review	Approved	Label Letter
May 29, 2013	Supplement 9Labeling · Standard review	Approved	Label Letter
Oct 23, 2012	Supplement 8Labeling · Standard review	Approved	Letter Label
May 22, 2012	Supplement 5Labeling · Standard review	Approved	Letter Pediatric Other
May 3, 2012	Supplement 7Manufacturing	Approved	Label
Jun 29, 2011	Supplement 1Labeling	Approved	Letter Label
Mar 11, 2011	Supplement 3Labeling · Standard review	Approved	Letter Label
Oct 29, 2010	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 200327
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters