Orange Book product · Brand (NDA)
MEFOXIN
CEFOXITIN SODIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CEFOXITIN SODIUM
Strength
EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 050517
Product number
003
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
- 1984MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 050581 · MERCK
- 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.
