Orange Book product · Brand (NDA)
CEFTIN
CEFUROXIME AXETIL
At a glance
Apr 29, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 29, 1997
29 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFUROXIME AXETIL
Strength
EQ 250MG BASE/5ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 050672
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1987CEFTINBrand (NDA)
NDA 050605 · GLAXOSMITHKLINE
- 2010CEFUROXIME AXETILGeneric (ANDA)
ANDA 065496 · ALKEM LABS LTD
- 2008CEFUROXIME AXETILGeneric (ANDA)
ANDA 065359 · ANDA REPOSITORY
- 2008CEFUROXIME AXETILGeneric (ANDA)
ANDA 065323 · SUN PHARM INDS LTD
- 2006CEFUROXIME AXETILGeneric (ANDA)
ANDA 065308 · AUROBINDO PHARMA
- 2005CEFUROXIME AXETILGeneric (ANDA)
ANDA 065166 · CHARTWELL RX
- 2004CEFUROXIME AXETILGeneric (ANDA)
ANDA 065190 · ANI PHARMS
- 2003CEFUROXIME AXETILGeneric (ANDA)
ANDA 065126 · FOSUN PHARMA
- 2003CEFUROXIME AXETILGeneric (ANDA)
ANDA 065135 · LUPIN
- 2003CEFUROXIME AXETILGeneric (ANDA)
ANDA 065118 · SUN PHARM INDS LTD
- 2002CEFUROXIME AXETILGeneric (ANDA)
ANDA 065069 · APOTEX
- 2002CEFUROXIME AXETILGeneric (ANDA)
ANDA 065043 · RANBAXY LABS LTD
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
