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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078169
Company: CHARTWELL RX

Products on ANDA 078169

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078169

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/2012	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
06/25/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/13/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/31/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078169

ESCITALOPRAM OXALATE

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	202389	ACCORD HLTHCARE
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	205619	AMNEAL PHARMS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	090432	AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078169	CHARTWELL RX
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078777	GRAVITI PHARMS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078604	INVAGEN PHARMS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	202280	JUBILANT CADISTA
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	202210	MACLEODS PHARMS LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078032	PRINSTON INC
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	090939	TORRENT PHARMS LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	077734	ZYDUS LIFESCIENCES
LEXAPRO	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Prescription	Yes	AB	021323	ABBVIE

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	202389	ACCORD HLTHCARE
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	205619	AMNEAL PHARMS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	090432	AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078169	CHARTWELL RX
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078777	GRAVITI PHARMS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078604	INVAGEN PHARMS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	202280	JUBILANT CADISTA
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	202210	MACLEODS PHARMS LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078032	PRINSTON INC
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	090939	TORRENT PHARMS LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077734	ZYDUS LIFESCIENCES
LEXAPRO	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	021323	ABBVIE

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202389	ACCORD HLTHCARE
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	205619	AMNEAL PHARMS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	090432	AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	078169	CHARTWELL RX
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	078777	GRAVITI PHARMS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	078604	INVAGEN PHARMS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202280	JUBILANT CADISTA
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202210	MACLEODS PHARMS LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	078032	PRINSTON INC
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	090939	TORRENT PHARMS LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	077734	ZYDUS LIFESCIENCES
LEXAPRO	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	Yes	AB	021323	ABBVIE

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