Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077660
Company: MYLAN PHARMS INC

• Other Important Information from FDA

Products on ANDA 077660

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077660

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077660s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/13/2009	SUPPL-2	Labeling		Label is not available on this site.
04/06/2009	SUPPL-1	Labeling		Label is not available on this site.