Orange Book product · Generic (ANDA)
CEFIXIME
CEFIXIME
At a glance
Dec 17, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 2024
1 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFIXIME
Strength
400MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 206358
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of CEFIXIME
- 2013SUPRAXBrand (NDA)
NDA 202091 · LUPIN LTD
- 2012SUPRAXBrand (NDA)
NDA 203195 · LUPIN LTD
- 1989SUPRAXBrand (NDA)
NDA 050622 · LEDERLE
- 1989SUPRAXBrand (NDA)
NDA 050621 · LEDERLE
- 2026CEFIXIMEGeneric (ANDA)
ANDA 218691 · FDC LTD
- 2026CEFIXIMEGeneric (ANDA)
ANDA 217607 · AUROBINDO PHARMA LTD
- 2021CEFIXIMEGeneric (ANDA)
ANDA 211775 · ALKEM LABS LTD
- 2018CEFIXIMEGeneric (ANDA)
ANDA 210574 · ALKEM LABS LTD
- 2017CEFIXIMEGeneric (ANDA)
ANDA 206144 · CHARTWELL RX
- 2017CEFIXIMEGeneric (ANDA)
ANDA 206938 · AJENAT PHARMS
- 2017CEFIXIMEGeneric (ANDA)
ANDA 206939 · AJENAT PHARMS
- 2015CEFIXIMEGeneric (ANDA)
ANDA 204835 · AUROBINDO PHARMA LTD
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.
