ALLERGAN FDA Approval NDA 021323

NDA 021323

ALLERGAN

FDA Drug Application

Application #021323

Documents

Letter2002-08-14
Letter2003-12-22
Letter2005-02-23
Letter2009-03-24
Letter2011-05-16
Letter2012-12-05
Letter2014-07-10
Label2002-08-14
Label2003-12-22
Label2007-08-03
Label2011-05-16
Label2011-03-11
Review2007-07-06
Review2007-07-06
Review2012-01-27
Other Important Information from FDA2005-07-29
Letter2002-08-29
Letter2003-12-22
Letter2005-01-13
Letter2004-05-26
Letter2007-08-07
Letter2008-09-19
Letter2008-10-21
Letter2009-03-24
Letter2009-02-03
Letter2011-03-16
Letter2014-11-03
Label2004-06-08
Label2003-12-22
Label2008-09-19
Label2009-03-25
Label2009-03-25
Label2009-02-04
Label2012-12-03
Label2014-11-04
Label2014-07-21
Review2004-04-12
Review2004-04-12
Review2012-01-27
Label2017-01-06
Letter2017-01-11
Medication Guide2017-01-11
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2019-01-14
Letter2019-01-18
Letter2020-09-01
Label2020-09-04
Letter2021-09-22
Label2021-09-24
Medication Guide2021-09-24

Application Sponsors

NDA 021323ALLERGAN

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 5MG BASE1LEXAPROESCITALOPRAM OXALATE
002TABLET;ORALEQ 10MG BASE1LEXAPROESCITALOPRAM OXALATE
003TABLET;ORALEQ 20MG BASE1LEXAPROESCITALOPRAM OXALATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2002-08-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2002-12-13STANDARD
EFFICACY; EfficacySUPPL3AP2003-12-18STANDARD
EFFICACY; EfficacySUPPL7AP2003-12-18STANDARD
S; SupplementSUPPL10AP2004-04-08STANDARD
LABELING; LabelingSUPPL14AP2005-01-11STANDARD
LABELING; LabelingSUPPL15AP2004-05-20STANDARD
LABELING; LabelingSUPPL20AP2005-02-18STANDARD
LABELING; LabelingSUPPL25AP2007-08-02STANDARD
LABELING; LabelingSUPPL28AP2008-09-18STANDARD
LABELING; LabelingSUPPL29AP2008-10-11STANDARD
EFFICACY; EfficacySUPPL30AP2009-03-19UNKNOWN
EFFICACY; EfficacySUPPL31AP2009-03-19UNKNOWN
LABELING; LabelingSUPPL32AP2009-01-30STANDARD
LABELING; LabelingSUPPL33AP2011-05-12STANDARD
LABELING; LabelingSUPPL35AP2011-03-11UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2013-03-07STANDARD
LABELING; LabelingSUPPL40AP2012-12-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL43AP2013-05-29STANDARD
LABELING; LabelingSUPPL44AP2014-10-31STANDARD
LABELING; LabelingSUPPL45AP2014-07-08901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL46AP2016-01-28STANDARD
LABELING; LabelingSUPPL47AP2017-01-04901 REQUIRED
LABELING; LabelingSUPPL51AP2019-01-11STANDARD
LABELING; LabelingSUPPL52AP2020-08-28STANDARD
LABELING; LabelingSUPPL53AP2021-09-20901 REQUIRED

Submissions Property Types

SUPPL2Null0
SUPPL10Null0
SUPPL30Null6
SUPPL31Null6
SUPPL33Null7
SUPPL35Null7
SUPPL39Null0
SUPPL40Null15
SUPPL43Null0
SUPPL44Null15
SUPPL45Null6
SUPPL46Null0
SUPPL47Null15
SUPPL51Null6
SUPPL52Null6
SUPPL53Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21323
            [companyName] => ALLERGAN
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/021323s047lbl.pdf#page=24"]
            [products] => [{"drugName":"LEXAPRO","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LEXAPRO","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LEXAPRO","activeIngredients":"ESCITALOPRAM OXALATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/11\/2019","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021323s051,021365s036lbl.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\\\/021323s047lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2014","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021323s044,021365s032lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2014","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021323Orig1s045,021365Orig1s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2012","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021323s040lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2011","submission":"SUPPL-33","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021323s033,021365s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2011","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021323s035,021365s025lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2009","submission":"SUPPL-31","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021323s030s031,021365s021s022lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2009","submission":"SUPPL-30","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021323s030s031,021365s021s022lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2009","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021323s032,021365s023lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2008","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021323s28s29,021365s18s19lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2007","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021323s025lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2003","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2003","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2002","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2002\\\/21-440.pdf_Lexapro_Prntlbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21323lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LEXAPRO","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LEXAPRO","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LEXAPRO","submission":"ESCITALOPRAM OXALATE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-01-11
        )

)
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