NDA 207986

OTONOMY INC

FDA Drug Application

Application #207986

Documents

• Letter: 2015-12-14
• Letter: 2016-01-28
• Label: 2015-12-15
• Label: 2016-02-18
• Review: 2016-02-19
• Summary Review: 2016-02-19
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Addendum: 1900-01-01
• Label: 2018-03-06
• Letter: 2018-03-15

Application Sponsors

NDA 207986

OTONOMY INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE, SUSPENSION;OTIC

6% (60MG/ML)

1

OTIPRIO

CIPROFLOXACIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2015-12-10	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2018-03-02	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	6

CDER Filings

OTONOMY INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207986
            [companyName] => OTONOMY INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OTIPRIO","activeIngredients":"CIPROFLOXACIN","strength":"6% (60MG\/ML)","dosageForm":"INJECTABLE, SUSPENSION;OTIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/02\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207986s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207986s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207986s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/10\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207986s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207986Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207986Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207986Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/02\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207986s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207986Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"01\/27\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207986s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207986Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-03-02
        )

)