ALLERGAN FDA Approval NDA 020822

NDA 020822

ALLERGAN

FDA Drug Application

Application #020822

Documents

Letter1998-07-17
Letter2004-05-26
Letter2005-02-23
Letter2007-08-07
Letter2008-09-19
Letter2009-02-03
Letter2011-08-17
Letter2012-12-05
Label2005-02-28
Label2007-08-03
Label2008-09-19
Label2009-02-04
Label2011-08-16
Label2012-12-03
Label2014-07-21
Review1998-07-17
Review2006-05-18
Review2011-10-11
Review2013-09-11
Letter2002-11-19
Letter2004-04-20
Letter2011-08-17
Letter2012-03-29
Letter2014-04-17
Letter2014-07-10
Label1998-07-17
Label2011-08-16
Label2012-03-28
Label2014-05-12
Review2011-10-11
Label2017-01-06
Medication Guide2017-01-11
Letter2017-01-11
Pediatric Medical Review1900-01-01
Pediatric Written Request1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Label2019-01-14
Letter2019-01-18
Letter2021-09-22
Label2021-09-24
Medication Guide2021-09-24
Letter2022-02-08
Label2022-02-08
Medication Guide2022-02-08

Application Sponsors

NDA 020822ALLERGAN

Marketing Status

Prescription001
Prescription002
Prescription003
Discontinued004

Application Products

001TABLET;ORALEQ 10MG BASE1CELEXACITALOPRAM HYDROBROMIDE
002TABLET;ORALEQ 20MG BASE1CELEXACITALOPRAM HYDROBROMIDE
003TABLET;ORALEQ 40MG BASE1CELEXACITALOPRAM HYDROBROMIDE
004TABLET;ORALEQ 60MG BASE0CELEXACITALOPRAM HYDROBROMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1998-07-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1999-08-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1999-10-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1999-12-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-12-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2000-07-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-04-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-06-27STANDARD
LABELING; LabelingSUPPL11AP2001-06-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2000-11-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2001-05-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-07-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2002-05-30STANDARD
LABELING; LabelingSUPPL19AP2002-11-19STANDARD
LABELING; LabelingSUPPL23AP2004-04-08STANDARD
LABELING; LabelingSUPPL27AP2004-05-20STANDARD
LABELING; LabelingSUPPL29AP2005-02-18STANDARD
LABELING; LabelingSUPPL34AP2007-08-02STANDARD
LABELING; LabelingSUPPL35AP2008-09-18STANDARD
LABELING; LabelingSUPPL37AP2009-01-30STANDARD
LABELING; LabelingSUPPL38AP2011-08-12STANDARD
LABELING; LabelingSUPPL40AP2011-08-12UNKNOWN
LABELING; LabelingSUPPL41AP2022-02-04STANDARD
LABELING; LabelingSUPPL42AP2012-03-27STANDARD
LABELING; LabelingSUPPL43AP2012-12-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL44AP2013-06-17STANDARD
LABELING; LabelingSUPPL45AP2014-04-16STANDARD
LABELING; LabelingSUPPL46AP2014-07-08901 REQUIRED
LABELING; LabelingSUPPL47AP2017-01-04901 REQUIRED
LABELING; LabelingSUPPL51AP2019-01-11STANDARD
LABELING; LabelingSUPPL52AP2021-09-20901 REQUIRED

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL10Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL38Null6
SUPPL40Null6
SUPPL41Null6
SUPPL42Null15
SUPPL43Null6
SUPPL44Null0
SUPPL45Null15
SUPPL46Null6
SUPPL47Null7
SUPPL51Null15
SUPPL52Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20822
            [companyName] => ALLERGAN
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/020822s047lbl.pdf#page=33"]
            [products] => [{"drugName":"CELEXA","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CELEXA","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CELEXA","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CELEXA","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 60MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/11\/2019","submission":"SUPPL-51","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020822s051lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020822s047lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2014","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020822Orig1s046lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020822s045lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2012","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020822s043lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2012","submission":"SUPPL-42","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020822s042,021046s019lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2011","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020822s038s040,021046s016s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2011","submission":"SUPPL-38","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020822s038s040,021046s016s017lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2009","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020822s037,021046s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2008","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020822s35,021046s14lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2007","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020822s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2005","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020822s29lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20822lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CELEXA","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CELEXA","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CELEXA","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CELEXA","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 60MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2019-01-11
        )

)
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