NDA 209963

GENUS LIFESCIENCES

FDA Drug Application

Application #209963

Documents

• Letter: 2017-12-20
• Review: 2018-04-30
• Label: 2018-09-05
• Letter: 2022-11-29
• Label: 2022-12-01

Application Sponsors

NDA 209963

GENUS LIFESCIENCES

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;NASAL

4%

1

GOPRELTO

COCAINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-12-14	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-11-28	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	4	Null	6

CDER Filings

GENUS LIFESCIENCES

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(
    [0] => Array
        (
            [ApplNo] => 209963
            [companyName] => GENUS LIFESCIENCES
            [docInserts] => ["",""]
            [products] => [{"drugName":"GOPRELTO","activeIngredients":"COCAINE HYDROCHLORIDE","strength":"4%","dosageForm":"SOLUTION;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/28\/2022","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209963s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2022","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209963s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209963lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/14\/2017","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\\\/2017\\\/209963lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209963Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209963Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/28\/2022","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209963s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/209963Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-11-28
        )

)