ANDA 208591

ALKEM LABS LTD

FDA Drug Application

Application #208591

Application Sponsors

ANDA 208591

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

0

ITRACONAZOLE

ITRACONAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-06-12	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-10-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208591
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ITRACONAZOLE","activeIngredients":"ITRACONAZOLE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/11\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/11\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/11\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-11
        )

)