Orange Book product · Brand (NDA)
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
CEFTRIAXONE SODIUM
At a glance
Apr 20, 2005
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 20, 2005
21 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFTRIAXONE SODIUM
Strength
EQ 2GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 050796
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.
- 1987ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINERBrand (NDA)
NDA 050624 · HOFFMANN LA ROCHE
- 1984ROCEPHINBrand (NDA)
NDA 050585 · HOFFMANN LA ROCHE
- 2024CEFTRIAXONEGeneric (ANDA)
ANDA 210197 · DEVA HOLDING AS
- 2018CEFTRIAXONEGeneric (ANDA)
ANDA 209218 · QILU ANTIBIOTICS
- 2018CEFTRIAXONEGeneric (ANDA)
ANDA 091049 · ASTRAL
- 2017CEFTRIAXONE SODIUMGeneric (ANDA)
ANDA 090701 · HIKMA
- 2017CEFTRIAXONE SODIUMGeneric (ANDA)
ANDA 091117 · ANDA REPOSITORY
- 2016CEFTRIAXONEGeneric (ANDA)
ANDA 203702 · QILU ANTIBIOTICS
- 2014CEFTRIAXONEGeneric (ANDA)
ANDA 090057 · SAMSON MEDCL
- 2013CEFTRIAXONEGeneric (ANDA)
ANDA 091068 · AGILA SPECLTS
- 2012CEFTRIAXONEGeneric (ANDA)
ANDA 202563 · HOSPIRA INC
- 2008CEFTRIAXONEGeneric (ANDA)
ANDA 065475 · BEDFORD
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.
