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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065135
Company: LUPIN
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/2003 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
05/27/2022 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

12/19/2019 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

12/19/2019 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

07/18/2017 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

03/24/2016 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

03/24/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

02/25/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

08/18/2008 SUPPL-6 Labeling

Label is not available on this site.

09/18/2008 SUPPL-3 Labeling

Label is not available on this site.

10/30/2007 SUPPL-2 Labeling

Label is not available on this site.

04/26/2005 SUPPL-1 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
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