ANDA 078644

PRINSTON INC

FDA Drug Application

Application #078644

Documents

• Letter: 2007-07-16

Application Sponsors

ANDA 078644

PRINSTON INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

	ORIG	1	AP	2012-05-22
LABELING; Labeling	SUPPL	2	AP	2015-01-20	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-06-29	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-06-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78644
            [companyName] => PRINSTON INC
            [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
        )

)