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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065496
Company: ALKEM LABS LTD

Products on ANDA 065496

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065496

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
05/27/2022	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 065496

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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