Orange Book product · Generic (ANDA)
CEFEPIME HYDROCHLORIDE
CEFEPIME HYDROCHLORIDE
At a glance
Jan 04, 2017
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 04, 2017
9 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFEPIME HYDROCHLORIDE
Strength
EQ 1GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 091048
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CEFEPIME HYDROCHLORIDE
- 2010CEFEPIME AND DEXTROSE IN DUPLEX CONTAINERBrand (NDA)
NDA 050821 · B BRAUN
- 2008CEFEPIME IN PLASTIC CONTAINERBrand (NDA)
NDA 050817 · BAXTER HLTHCARE
- 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
- 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.
