Orange Book product · Generic (ANDA)
CEFUROXIME SODIUM
CEFUROXIME SODIUM
At a glance
Jan 09, 2004
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 09, 2004
22 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFUROXIME SODIUM
Strength
EQ 750MG BASE/VIAL
Dosage form
INJECTABLE
Route
INTRAMUSCULAR, INTRAVENOUS
TE code
AB
Application
ANDA 065048
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of CEFUROXIME SODIUM
- 2001CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINERBrand (NDA)
NDA 050780 · B BRAUN
- 1989ZINACEF IN PLASTIC CONTAINERBrand (NDA)
NDA 050643 · PAI HOLDINGS PHARM
- 1983ZINACEFBrand (NDA)
NDA 050558 · PAI HOLDINGS PHARM
- 2009CEFUROXIME SODIUM IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 065251 · SAMSON MEDCL
- 2008CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065483 · HOSPIRA INC
- 2008CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065503 · HOSPIRA INC
- 2008CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065484 · HOSPIRA INC
- 2004CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065046 · HIKMA
- 2001CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065001 · FRESENIUS KABI USA
- 1998CEFUROXIME SODIUMGeneric (ANDA)
ANDA 065002 · FRESENIUS KABI USA
- 1998CEFUROXIME SODIUMGeneric (ANDA)
ANDA 064191 · TEVA PHARMS
- 1998CEFUROXIME SODIUMGeneric (ANDA)
ANDA 064192 · TEVA PHARMS
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.
