NDA 207920

ASTRAZENECA LP

FDA Drug Application

Application #207920

Documents

• Label: 2018-11-27
• Letter: 2018-11-27
• Label: 2018-11-27
• Letter: 2018-11-27
• Label: 2018-11-27
• Review: 2018-11-27
• Summary Review: 2018-11-27
• Review: 2019-01-15
• Label: 2019-04-08
• Letter: 2019-04-08
• Letter: 2022-09-07
• Label: 2022-09-09

Application Sponsors

NDA 207920

ASTRAZENECA LP

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

EQ 20MG BASE

1

NEXIUM 24HR

ESOMEPRAZOLE MAGNESIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2015-11-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-12-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-04-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-09-06	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	5	Null	15
SUPPL	7	Null	7

CDER Filings

ASTRAZENECA LP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207920
            [companyName] => ASTRAZENECA LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEXIUM 24HR","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/04\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207920Orig1s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207920Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207920orig1s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207920Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/23\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207920Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207920Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207920Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207920Orig1s000SumR.pdf\"}]","notes":">"}]
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            [actionDate] => 2019-04-04
        )

)