Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210568
Company: ALKEM LABS LTD

Products on ANDA 210568

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210568

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210568

CEFPODOXIME PROXETIL

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	210568	ALKEM LABS LTD
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	065388	ANDA REPOSITORY
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	065370	AUROBINDO PHARMA
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	065462	SANDOZ

TABLET;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	210568	ALKEM LABS LTD
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	065388	ANDA REPOSITORY
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	065370	AUROBINDO PHARMA
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	065462	SANDOZ