Orange Book product · Brand (NDA)
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
At a glance
Mar 08, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 08, 2024
2 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFAZOLIN SODIUM
Strength
EQ 3GM BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 211413
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2022CEFAZOLIN SODIUMBrand (NDA)
NDA 216109 · HIKMA
- 2021CEFAZOLIN IN DEXTROSEBrand (NDA)
NDA 207131 · BAXTER HLTHCARE CORP
- 2000CEFAZOLIN AND DEXTROSEBrand (NDA)
NDA 050779 · B BRAUN
- 1983ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 050566 · BAXTER HLTHCARE
- —ANCEFBrand (NDA)
NDA 050461 · GLAXOSMITHKLINE
- 2018CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 209217 · QILU ANTIBIOTICS
- 2016CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 201654 · HOSPIRA
- 2015CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 203661 · QILU ANTIBIOTICS
- 2009CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 065280 · CEPHAZONE PHARMA
- 2009CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 065295 · CEPHAZONE PHARMA
- 2009CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 065296 · CEPHAZONE PHARMA
- 2008CEFAZOLIN SODIUMGeneric (ANDA)
ANDA 065303 · ACS DOBFAR
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.
