Orange Book product · Generic (ANDA)
CEPHALEXIN
CEPHALEXIN
At a glance
Mar 26, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 26, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CEPHALEXIN
Strength
EQ 125MG BASE/5ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 210221
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CEPHALEXIN
- —KEFLEXBrand (NDA)
NDA 050405 · PRAGMA
- —KEFLEXBrand (NDA)
NDA 050406 · PRAGMA
- 2026CEPHALEXINGeneric (ANDA)
ANDA 213568 · AUROBINDO PHARMA
- 2024CEPHALEXINGeneric (ANDA)
ANDA 218947 · ALKEM LABS LTD
- 2024CEPHALEXINGeneric (ANDA)
ANDA 218817 · AUROBINDO PHARMA 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.
