ANDA 200480

NOVOCOL INC

FDA Drug Application

Application #200480

Application Sponsors

ANDA 200480

NOVOCOL INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;TOPICAL	0.5%	0	DYCLOPRO	DYCLONINE HYDROCHLORIDE
002	SOLUTION;TOPICAL	1%	0	DYCLOPRO	DYCLONINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2018-11-20

Submissions Property Types

ORIG

1

Null

19

CDER Filings

NOVOCOL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200480
            [companyName] => NOVOCOL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DYCLOPRO","activeIngredients":"DYCLONINE HYDROCHLORIDE","strength":"0.5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"DYCLOPRO","activeIngredients":"DYCLONINE HYDROCHLORIDE","strength":"1%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-20
        )

)