ANDA 210199

ZYDUS PHARMS

FDA Drug Application

Application #210199

Application Sponsors

ANDA 210199

ZYDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

0.05%

0

CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-10-27	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-10-07	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210199
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-27
        )

)