Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078766
Company: HIKMA PHARMS

Products on ANDA 078766

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 078766

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
09/03/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/03/2015	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/21/2012	SUPPL-2	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.