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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062713
Company: AJENAT PHARMS

Products on ANDA 062713

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062713

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/1988	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
05/04/2011	SUPPL-5	Labeling		Label is not available on this site.
03/22/1989	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/27/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062713

CEPHALEXIN

CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	062713	AJENAT PHARMS
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	090836	ALKEM LABS LTD
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	065248	ANDA REPOSITORY
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	065253	AUROBINDO PHARMA
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	065152	CHARTWELL RX
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	065229	LUPIN
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	062702	TEVA

CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	062713	AJENAT PHARMS
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	090836	ALKEM LABS LTD
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065248	ANDA REPOSITORY
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065253	AUROBINDO PHARMA
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065152	CHARTWELL RX
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	065229	LUPIN
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	062702	TEVA

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