ANDA 208616

AUROBINDO PHARMA LTD

FDA Drug Application

Application #208616

Application Sponsors

ANDA 208616

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

100MG

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-11-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-08-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-08-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-11-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208616
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/21\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/21\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-21
        )

)