ANDA 077534

INVAGEN PHARMS

FDA Drug Application

Application #077534

Application Sponsors

ANDA 077534

INVAGEN PHARMS

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	2006-10-03
LABELING; Labeling	SUPPL	2	AP	2009-08-21
LABELING; Labeling	SUPPL	4	AP	2012-04-25
LABELING; Labeling	SUPPL	6	AP	2013-04-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-03-09	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-11-21	STANDARD
LABELING; Labeling	SUPPL	17	AP	2022-11-21	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-11-21	STANDARD
LABELING; Labeling	SUPPL	20	AP	2022-11-21	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	4	Null	8
SUPPL	6	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	14	Null	7
SUPPL	17	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77534
            [companyName] => INVAGEN PHARMS
            [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
        )

)