ANDA 078032

PRINSTON INC

FDA Drug Application

Application #078032

Documents

• Letter: 2011-05-10
• Other Important Information from FDA: 2007-01-18

Application Sponsors

ANDA 078032

PRINSTON INC

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

2015-08-28

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78032
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESCITALOPRAM OXALATE","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESCITALOPRAM OXALATE","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)