NDA 208056

TAKEDA PHARMS USA

FDA Drug Application

Application #208056

Documents

• Label: 2016-02-03
• Label: 2016-07-20
• Letter: 2016-02-03
• Letter: 2016-07-12
• Letter: 2016-11-10
• Label: 2016-11-10
• Review: 2017-07-20

Application Sponsors

NDA 208056

TAKEDA PHARMS USA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL

30MG

1

DEXILANT SOLUTAB

DEXLANSOPRAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2016-01-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-10-24	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	6

CDER Filings

TAKEDA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208056
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXILANT SOLUTAB","activeIngredients":"DEXLANSOPRAZOLE","strength":"30MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/24\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022287s025_0208056s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-1","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022287s021s022s023,208056s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208056lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/26\/2016","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\\\/2016\\\/208056lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208056Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208056Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/24\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022287s025_0208056s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/022287Orig1s026,208056Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"07\/08\/2016","submission":"SUPPL-1","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022287s021s022s023,208056s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/022287Orig1s021,s022,s023,208056Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2016-10-24
        )

)