CEFUROXIME AXETIL از شرکت ALKEM LABS LTD

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CEFUROXIME AXETIL از شرکت ALKEM LABS LTD

Abbreviated New Drug Application (ANDA): 065496

Company: ALKEM LABS LTD

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
06/07/2010 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
12/19/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/19/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

03/10/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/19/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/24/2016 SUPPL-4 Labeling-Package Insert

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 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 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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