Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076765
Company: TEVA PHARMS USA

• Other Important Information from FDA

Products on ANDA 076765

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 5MG BASE	TABLET;ORAL	Discontinued	None	No	No
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No
ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE	EQ 20MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076765

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) Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076765LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076765s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076765Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2022	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2022	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2022	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2022	SUPPL-8	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/19/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/12/2014	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/28/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.