ANDA 208800

TARO PHARM INDS LTD

FDA Drug Application

Application #208800

Documents

• Letter: 2019-03-12

Application Sponsors

ANDA 208800

TARO PHARM INDS LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

DEFERIPRONE

DEFERIPRONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-02-08	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-12-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208800
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFERIPRONE","activeIngredients":"DEFERIPRONE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208800Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-08
        )

)