Orange Book product · Generic (ANDA)
CEFTRIAXONE
CEFTRIAXONE SODIUM
At a glance
Jan 12, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 12, 2024
2 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFTRIAXONE SODIUM
Strength
EQ 1GM BASE/VIAL
Dosage form
INJECTABLE
Route
INTRAMUSCULAR, INTRAVENOUS
TE code
Not listed
Application
ANDA 210197
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CEFTRIAXONE SODIUM
- 2005CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERBrand (NDA)
NDA 050796 · B BRAUN
- 1987ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINERBrand (NDA)
NDA 050624 · HOFFMANN LA ROCHE
- 1984ROCEPHINBrand (NDA)
NDA 050585 · HOFFMANN LA ROCHE
- 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.
