An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065308
Company: AUROBINDO PHARMA

Products on ANDA 065308

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065308

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
09/22/2021	SUPPL-20	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.
12/19/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 065308

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	065359	ANDA REPOSITORY
CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	065308	AUROBINDO PHARMA
CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 125MG BASE	TABLET;ORAL	Prescription	No	AB	065166	CHARTWELL RX

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

Top