ceftaroline fosamil Injectable Solution

Brand(s)
Teflaro
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Forest Laboratories, Inc (2015-08-31)
Oldest Current Product
2010-10-29
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\CEFTAROLINE FOSAMIL
FDAOB
IV (INFUSION)\POWDER\CEFTAROLINE FOSAMIL\rdfq
SPL Active
INTRAVENOUS\POWDER, FOR SOLUTION\CEFTAROLINE FOSAMIL
SPL Moiety
INTRAVENOUS\POWDER, FOR SOLUTION\CEFTAROLINE

product(s) by strength(s)

ceftaroline fosamil 20 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004560400TeflaroNDAForest Laboratories, Inc2010-10-29CEFTAROLINE FOSAMILINTRAVENOUSPOWDER, FOR SOLUTIONNDA2003273ecde48b-75a2-4beb-9999-369f3f61bb8a

ceftaroline fosamil 30 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004560600TeflaroNDAForest Laboratories, Inc2010-10-29CEFTAROLINE FOSAMILINTRAVENOUSPOWDER, FOR SOLUTIONNDA2003273ecde48b-75a2-4beb-9999-369f3f61bb8a

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA200327TEFLAROCEREXA INC2010-10-29p6906055, SUBSTANCE
p6417175, METHODS FOR TREATING BACTERIAL INFECTIONS, SUBSTANCE
p7419973, SUBSTANCE
p8247400, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
NEW CHEMICAL ENTITY [2015-10-29]NDA200327_001, NDA200327_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA200327_001RXCEFTAROLINE FOSAMIL (400MG/VIAL)POWDERFalse2010-10-29TEFLARO
2NDA200327_002RXCEFTAROLINE FOSAMIL (600MG/VIAL)POWDERTrue2010-10-29TEFLARO

patent(s)

#idexpiration dateapplication(s)
1p6417175 (view patent)2022-04-11NDA200327
2p6906055 (view patent)2021-12-15NDA200327
3p7419973 (view patent)2021-12-15NDA200327
4p8247400 (view patent)2031-02-10NDA200327

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13ecde48b-75a2-4beb-9999-369f3f61bb8a (view SPL)These highlights do not include all the information needed to use TEFLARO safely and effectively. See full prescribing information for TEFLARO.TEFLARO (ceftaroline fosamil) for injection, for intravenous useInitial U.S. Approval: 2010prescriptionHuman PrescriptionForest Laboratories, IncANALYSIS, MANUFACTURE, PACK2015-08-3117004560400, 004560600

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