aflibercept Injectable Solution

Brand(s)
Eylea, Zaltrap
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2015-09-02)
Oldest Current Product
2011-11-21
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\AFLIBERCEPT
SPL Active
INTRAVENOUS\SOLUTION, CONCENTRATE\AFLIBERCEPT
INTRAVITREAL\INJECTION, SOLUTION\AFLIBERCEPT
SPL Moiety
INTRAVENOUS\SOLUTION, CONCENTRATE\AFLIBERCEPT
INTRAVITREAL\INJECTION, SOLUTION\AFLIBERCEPT

product(s) by strength(s)

aflibercept 40 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1617550005EyleaBLARegeneron Pharmaceuticals, Inc.2011-11-21AFLIBERCEPTINTRAVITREALINJECTION, SOLUTION125387f96cfd69-da34-41ee-90a9-610a4655cd1c

ziv-aflibercept 25 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000245840ZaltrapBLASanofi-Aventis U.S. Llc2012-08-03AFLIBERCEPTINTRAVENOUSSOLUTION, CONCENTRATE125418f6725df6-50ee-4b0a-b900-d02ba634395d

application(s)

#idtitleapprovedtradenamesfda division
1125387aflibercept Application2011-11-18EyleaCDER
2125418ziv-aflibercept Application2012-08-03ZaltrapCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f6725df6-50ee-4b0a-b900-d02ba634395d (view SPL)These highlights do not include all the information needed to use ZALTRAP safely and effectively. See full prescribing information for ZALTRAP. ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion Initial U.S. Approval: 2012prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-09-0214000245840, 000245841
2f96cfd69-da34-41ee-90a9-610a4655cd1c (view SPL)These highlights do not include all the information needed to use EYLEA safely and effectively. See full prescribing information for EYLEA. EYLEA (aflibercept) Injection For Intravitreal Injection Initial U.S. Approval: 2011prescriptionHuman PrescriptionRegeneron Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE2015-08-0312617550005

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