Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202227
Company: AMNEAL PHARMS

Products on ANDA 202227

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 202227

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202227s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/15/2024	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/10/2021	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/20/2021	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/03/2021	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/03/2021	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/03/2021	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/14/2015	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/10/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
12/19/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202227

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