ANDA 209460

TORRENT

FDA Drug Application

Application #209460

Application Sponsors

ANDA 209460

TORRENT

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

0

ITRACONAZOLE

ITRACONAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-08-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-10-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209460
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ITRACONAZOLE","activeIngredients":"ITRACONAZOLE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/21\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-21
        )

)