ANDA 206879

MACLEODS PHARMS LTD

FDA Drug Application

Application #206879

Application Sponsors

ANDA 206879

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

400MG

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-10-06	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-08-14	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206879
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/14\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-14
        )

)