avibactam / Ceftazidime Injection

Brand(s)
Avycaz
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Forest Laboratories, Inc (2015-09-08)
Oldest Current Product
2014-12-26
License(s)
NDA
RxNORM
INJECTION\AVIBACTAM:CEFTAZIDIME
FDAOB
IV (INFUSION)\POWDER\AVIBACTAM SODIUM: CEFTAZIDIME\rdfq
SPL Active
INTRAVENOUS\POWDER, FOR SOLUTION\AVIBACTAM SODIUM: CEFTAZIDIME
SPL Moiety
INTRAVENOUS\POWDER, FOR SOLUTION\AVIBACTAM: CEFTAZIDIME ANHYDROUS

product(s) by strength(s)

avibactam 500 mg / ceftazidime 2000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004562700AvycazNDAForest Laboratories, Inc2014-12-26AVIBACTAM SODIUM, CEFTAZIDIMEINTRAVENOUSPOWDER, FOR SOLUTIONNDA206494d9c2803f-dc9c-4b19-b4a3-8303bc8c15fd

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA206494AVYCAZCEREXA INC2015-02-25p7112592, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
p8835455, SUBSTANCE
p8969566
p8471025
p8178554, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
p7612087, SUBSTANCE
NDA206494_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA206494_001RXAVIBACTAM SODIUM (EQ 0.5GM BASE), CEFTAZIDIME (2GM/VIAL)POWDERTrue2015-02-25AVYCAZ

patent(s)

#idexpiration dateapplication(s)
1p7112592 (view patent)2022-02-24NDA206494
2p7612087 (view patent)2026-11-12NDA206494
3p8178554 (view patent)2021-07-24NDA206494
4p8471025 (view patent)2031-08-12NDA206494
5p8835455 (view patent)2030-10-08NDA206494
6p8969566 (view patent)2032-06-15NDA206494

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1d9c2803f-dc9c-4b19-b4a3-8303bc8c15fd (view SPL)These highlights do not include all the information needed to use AVYCAZ safely and effectively. See full prescribing information for AVYCAZ.AVYCAZ (ceftazidime and avibactam) for injection, for intravenous useInitial U.S. Approval: 2015prescriptionHuman PrescriptionForest Laboratories, Inc2015-09-082004562700

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII