NDA 207070

BOEHRINGER INGELHEIM

FDA Drug Application

Application #207070

Documents

• Review: 2016-06-27
• Summary Review: 2015-09-17
• Letter: 2015-09-17
• Label: 2015-09-23
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Addendum: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Addendum: 1900-01-01

Application Sponsors

NDA 207070

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

SPRAY;INHALATION

2.5MCG

0

SPIRIVA RESPIMAT

TIOTROPIUM BROMIDE

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval

ORIG

1

AP

2015-09-15

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207070
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPIRIVA RESPIMAT","activeIngredients":"TIOTROPIUM BROMIDE","strength":"2.5MCG","dosageForm":"SPRAY;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/15\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207070s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/15\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207070s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207070Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207070Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207070Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2015-09-15
        )

)