U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065069
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET;ORAL Prescription AB No No
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/02/2002 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/09/2022 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

12/19/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

12/19/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/11/2017 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

03/24/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

09/22/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

01/06/2009 SUPPL-9 Labeling

Label is not available on this site.

09/01/2005 SUPPL-5 Labeling

Label is not available on this site.

CEFUROXIME AXETIL

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET;ORAL Prescription No AB 065496 ALKEM LABS LTD
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET;ORAL Prescription No AB 065359 ANDA REPOSITORY
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET;ORAL Prescription No AB 065069 APOTEX
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET;ORAL Prescription No AB 065308 AUROBINDO PHARMA
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET;ORAL Prescription No AB 065166 CHARTWELL RX
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET;ORAL Prescription No AB 065135 LUPIN

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET;ORAL Prescription No AB 065496 ALKEM LABS LTD
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET;ORAL Prescription No AB 065359 ANDA REPOSITORY
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET;ORAL Prescription No AB 065069 APOTEX
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET;ORAL Prescription No AB 065308 AUROBINDO PHARMA
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET;ORAL Prescription No AB 065166 CHARTWELL RX
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET;ORAL Prescription No AB 065135 LUPIN
Back to Top