FDA Orange Book · active-ingredient family
Cefepime hydrochloride
Cefepime hydrochloride is approved as 3 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER · NDA 050821
3
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFEPIME AND DEXTROSE IN DUPLEX CONTAINERRLD×2 | B BRAUN | NDA 050821 | — | May 06, 2010 | |
| CEFEPIME IN PLASTIC CONTAINERRLD×2 | BAXTER HLTHCARE | NDA 050817 | — | Aug 05, 2008 | |
| MAXIPIMERLD×3 | HOSPIRA INC | NDA 050679 | — | Jan 18, 1996 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFEPIME HYDROCHLORIDE×2 | HIKMA | ANDA 214402 | AP | May 22, 2024 | |
| CEFEPIME HYDROCHLORIDE×2 | ASTRAL | ANDA 212721 | — | Jul 21, 2020 | |
| CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER | SAMSON MEDCL | ANDA 209408 | — | Aug 21, 2018 | |
| CEFEPIME HYDROCHLORIDE×2 | SAGENT PHARMS INC | ANDA 091048 | AP | Jan 04, 2017 | |
| CEFEPIME HYDROCHLORIDE×3 | QILU ANTIBIOTICS | ANDA 203704 | AP | Feb 01, 2016 | |
| CEFEPIME HYDROCHLORIDE×2 | HOSPIRA INC | ANDA 202268 | — | Jul 30, 2012 | |
| CEFEPIME HYDROCHLORIDE×3 | CHARTWELL RX | ANDA 090291 | — | Dec 21, 2010 | |
| CEFEPIME HYDROCHLORIDE×2 | ACS DOBFAR | ANDA 065441 | AP | Mar 20, 2008 | |
| CEFEPIME HYDROCHLORIDE×3 | HOSPIRA INC | ANDA 065369 | — | Jun 18, 2007 |
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.
Cefepime hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
