Orange Book product · Brand (NDA)
MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
CEFOXITIN SODIUM
At a glance
Sep 20, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 20, 1984
42 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFOXITIN SODIUM
Strength
EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050581
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2006CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINERBrand (NDA)
NDA 065214 · B BRAUN
- —MEFOXINBrand (NDA)
NDA 050517 · PHARMOBEDIENT
- 2015CEFOXITIN IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 200938 · SAMSON MEDCL
- 2011CEFOXITINGeneric (ANDA)
ANDA 065467 · ACS DOBFAR SPA
- 2011CEFOXITINGeneric (ANDA)
ANDA 065464 · ACS DOBFAR SPA
- 2010CEFOXITINGeneric (ANDA)
ANDA 065415 · ACS DOBFAR
- 2010CEFOXITINGeneric (ANDA)
ANDA 065238 · HIKMA FARMACEUTICA
- 2010CEFOXITINGeneric (ANDA)
ANDA 065239 · HIKMA FARMACEUTICA
- 2009CEFOXITINGeneric (ANDA)
ANDA 065414 · ACS DOBFAR
- 2006CEFOXITINGeneric (ANDA)
ANDA 065312 · HOSPIRA INC
- 2006CEFOXITINGeneric (ANDA)
ANDA 065313 · HOSPIRA INC
- 2000CEFOXITINGeneric (ANDA)
ANDA 065051 · HIKMA
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.
