NDA 208032

ST RENATUS

FDA Drug Application

Application #208032

Documents

• Letter: 2016-07-11
• Label: 2016-07-08
• Review: 2017-11-28
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2018-11-05
• Letter: 2018-11-09

Application Sponsors

NDA 208032

ST RENATUS

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.1MG/SPRAY;6MG/SPRAY

1

KOVANAZE

OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2016-06-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2018-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

CDER Filings

ST RENATUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208032
            [companyName] => ST RENATUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"KOVANAZE","activeIngredients":"OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE","strength":"0.1MG\/SPRAY;6MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208032s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208032s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208032s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208032Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208032Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208032s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208032Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-11-02
        )

)