ANDA 078766

HIKMA PHARMS

FDA Drug Application

Application #078766

Application Sponsors

ANDA 078766

HIKMA PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE
002	TABLET;ORAL	EQ 10MG BASE	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE
003	TABLET;ORAL	EQ 20MG BASE	0	ESCITALOPRAM OXALATE	ESCITALOPRAM OXALATE

FDA Submissions

	ORIG	1	AP	2012-09-11
LABELING; Labeling	SUPPL	2	AP	2012-11-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-09-03	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-09-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78766
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)