ANDA 210549

TARO

FDA Drug Application

Application #210549

Application Sponsors

ANDA 210549

TARO

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

15%

0

AZELAIC ACID

AZELAIC ACID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-08-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-10-31	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-10-31	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	4	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210549
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZELAIC ACID","activeIngredients":"AZELAIC ACID","strength":"15%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/31\/2022","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2022","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2022-10-31
        )

)