ANDA 203080

MICRO LABS LTD

FDA Drug Application

Application #203080

Application Sponsors

ANDA 203080

MICRO LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2012-05-22
LABELING; Labeling	SUPPL	2	AP	2020-07-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-07-21	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AB

CDER Filings

MICRO LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203080
            [companyName] => MICRO LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/22\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-05-22
        )

)