ANDA 077032

SUN PHARM INDS INC

FDA Drug Application

Application #077032

Documents

• Other Important Information from FDA: 2005-07-29

Application Sponsors

ANDA 077032

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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	2004-11-12
LABELING; Labeling	SUPPL	2	AP	2005-05-11
LABELING; Labeling	SUPPL	3	AP	2005-05-27
LABELING; Labeling	SUPPL	6	AP	2006-02-14
LABELING; Labeling	SUPPL	7	AP	2006-09-13
LABELING; Labeling	SUPPL	10	AP	2007-06-28
LABELING; Labeling	SUPPL	11	AP	2007-10-25
LABELING; Labeling	SUPPL	13	AP	2009-02-19
LABELING; Labeling	SUPPL	14	AP	2009-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2010-08-04
LABELING; Labeling	SUPPL	17	AP	2012-12-27
LABELING; Labeling	SUPPL	21	AP	2012-12-27	STANDARD

Submissions Property Types

SUPPL	17	Null	15
SUPPL	21	Null	15

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77032
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)