Orange Book product · Brand (NDA)
KEFLEX
CEPHALEXIN
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
CEPHALEXIN
Strength
EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 050406
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.
- —KEFLEXBrand (NDA)
NDA 050405 · PRAGMA
- 2026CEPHALEXINGeneric (ANDA)
ANDA 213568 · AUROBINDO PHARMA
- 2024CEPHALEXINGeneric (ANDA)
ANDA 218947 · ALKEM LABS LTD
- 2024CEPHALEXINGeneric (ANDA)
ANDA 218817 · AUROBINDO PHARMA LTD
- 2019CEPHALEXINGeneric (ANDA)
ANDA 210221 · ALKEM LABS LTD
- 2010CEPHALEXINGeneric (ANDA)
ANDA 090836 · ALKEM LABS LTD
- 2009CEPHALEXINGeneric (ANDA)
ANDA 065444 · HIKMA PHARMS
- 2007CEPHALEXINGeneric (ANDA)
ANDA 065336 · YUNG SHIN PHARM
- 2006CEPHALEXINGeneric (ANDA)
ANDA 065326 · CHARTWELL RX
- 2006CEPHALEXINGeneric (ANDA)
ANDA 065215 · HIKMA
- 2005CEPHALEXINGeneric (ANDA)
ANDA 065229 · LUPIN
- 2005CEPHALEXINGeneric (ANDA)
ANDA 065253 · AUROBINDO PHARMA
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.
