Orange Book product · Generic (ANDA)
ROCEPHIN
CEFTRIAXONE SODIUM
At a glance
Apr 30, 1987
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 30, 1987
39 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFTRIAXONE SODIUM
Strength
EQ 1GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 062654
Product number
002
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
- 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
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.
