Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079121
Company: TARO

Products on ANDA 079121

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079121

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/2012	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
03/08/2024	SUPPL-13	Labeling-Patient Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/21/2021	SUPPL-11	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/08/2021	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/08/2021	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/08/2021	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/04/2014	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/20/2013	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/20/2013	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 079121

ESCITALOPRAM OXALATE

SOLUTION;ORAL; EQ 5MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	202227	AMNEAL PHARMS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	079062	AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	090477	CHARTWELL MOLECULAR
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	202221	HETERO LABS LTD III
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	202754	MACLEODS PHARMS LTD
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	079121	TARO