NDA 207923

NOVARTIS

FDA Drug Application

Application #207923

Documents

• Label: 2015-11-03
• Letter: 2015-11-03
• Review: 2016-12-06
• Summary Review: 2016-12-06
• Letter: 2017-01-24
• Label: 2017-01-24
• Letter: 2021-08-02
• Label: 2021-08-02

Application Sponsors

NDA 207923

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

POWDER;INHALATION

15.6MCG/INH

1

SEEBRI

GLYCOPYRROLATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2015-10-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-01-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-07-30	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	15
SUPPL	5	Null	7

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207923
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEEBRI","activeIngredients":"GLYCOPYRROLATE","strength":"15.6MCG\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/30\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207923s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207923s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207923lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/29\/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\\\/207923lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207923Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207923Orig1_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207923Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/30\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207923s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/207923Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/19\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207923s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207923Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"05\/23\/2016","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-07-30
        )

)