Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065308
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 125MG BASE TABLET;ORAL Prescription AB No No
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
03/29/2006 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
07/18/2017 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/10/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/10/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/10/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/21/2007 SUPPL-1 Labeling

Label is not available on this site.

CEFUROXIME AXETIL

TABLET;ORAL; EQ 125MG 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 125MG BASE TABLET;ORAL Prescription No AB 065308 AUROBINDO PHARMA LTD
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 125MG BASE TABLET;ORAL Prescription No AB 065359 ORCHID HLTHCARE
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 125MG BASE TABLET;ORAL Prescription No AB 065166 WOCKHARDT

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 065190 ANI PHARMS INC
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 LTD
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET;ORAL Prescription No AB 065135 LUPIN
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET;ORAL Prescription No AB 065359 ORCHID HLTHCARE
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE TABLET;ORAL Prescription No AB 065166 WOCKHARDT

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 065190 ANI PHARMS INC
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 LTD
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET;ORAL Prescription No AB 065135 LUPIN
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET;ORAL Prescription No AB 065359 ORCHID HLTHCARE
CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 500MG BASE TABLET;ORAL Prescription No AB 065166 WOCKHARDT

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