ANDA 210038

GENZUM

FDA Drug Application

Application #210038

Application Sponsors

ANDA 210038

GENZUM

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

2.0%

0

NAFTIFINE HYDROCHLORIDE

NAFTIFINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-09-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-10-06	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

GENZUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210038
            [companyName] => GENZUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAFTIFINE HYDROCHLORIDE","activeIngredients":"NAFTIFINE HYDROCHLORIDE","strength":"2.0%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-22
        )

)