ANDA 077289

AMNEAL PHARMS NY

FDA Drug Application

Application #077289

Application Sponsors

ANDA 077289

AMNEAL PHARMS NY

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 10MG BASE	0	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE
002	TABLET;ORAL	EQ 20MG BASE	0	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE
003	TABLET;ORAL	EQ 40MG BASE	0	CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE

FDA Submissions

	ORIG	1	AP	2006-11-30
LABELING; Labeling	SUPPL	3	AP	2008-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2011-01-13
LABELING; Labeling	SUPPL	8	AP	2012-04-25
LABELING; Labeling	SUPPL	15	AP	2014-11-03	STANDARD
LABELING; Labeling	SUPPL	18	AP	2014-11-03	STANDARD
LABELING; Labeling	SUPPL	19	AP	2014-11-03	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	8	Null	15
SUPPL	15	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77289
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)