Orange Book product · Brand (NDA)
CEFEPIME IN PLASTIC CONTAINER
CEFEPIME HYDROCHLORIDE
At a glance
Aug 05, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 05, 2008
18 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFEPIME HYDROCHLORIDE
Strength
EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050817
Product number
001
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.
- 2010CEFEPIME AND DEXTROSE IN DUPLEX CONTAINERBrand (NDA)
NDA 050821 · B BRAUN
- 1996MAXIPIMEBrand (NDA)
NDA 050679 · HOSPIRA INC
- 2024CEFEPIME HYDROCHLORIDEGeneric (ANDA)
ANDA 214402 · HIKMA
- 2020CEFEPIME HYDROCHLORIDEGeneric (ANDA)
ANDA 212721 · ASTRAL
- 2018CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 209408 · SAMSON MEDCL
- 2017CEFEPIME HYDROCHLORIDEGeneric (ANDA)
ANDA 091048 · SAGENT PHARMS INC
- 2016CEFEPIME HYDROCHLORIDEGeneric (ANDA)
ANDA 203704 · QILU ANTIBIOTICS
- 2012CEFEPIME HYDROCHLORIDEGeneric (ANDA)
ANDA 202268 · HOSPIRA INC
- 2010CEFEPIME HYDROCHLORIDEGeneric (ANDA)
ANDA 090291 · CHARTWELL RX
- 2008CEFEPIME HYDROCHLORIDEGeneric (ANDA)
ANDA 065441 · ACS DOBFAR
- 2007CEFEPIME HYDROCHLORIDEGeneric (ANDA)
ANDA 065369 · 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.
