ANDA 078584

HETERO LABS LTD III

FDA Drug Application

Application #078584

Documents

• Letter: 2007-08-14

Application Sponsors

ANDA 078584

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

	ORIG	1	AP	2012-05-22
LABELING; Labeling	SUPPL	11	AP	2012-09-14	STANDARD
LABELING; Labeling	SUPPL	13	AP	2013-03-20	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-06-24	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-06-24	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	11	Null	1
SUPPL	13	Null	1
SUPPL	18	Null	7
SUPPL	19	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78584
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEVIRAPINE","submission":"NEVIRAPINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)