ANDA 076796

PRINSTON INC

FDA Drug Application

Application #076796

Application Sponsors

ANDA 076796

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	20MG	0	FUROSEMIDE	FUROSEMIDE
002	TABLET;ORAL	40MG	0	FUROSEMIDE	FUROSEMIDE
003	TABLET;ORAL	80MG	0	FUROSEMIDE	FUROSEMIDE

FDA Submissions

	ORIG	1	AP	2004-03-26
LABELING; Labeling	SUPPL	2	AP	2006-05-01
LABELING; Labeling	SUPPL	4	AP	2007-08-09
LABELING; Labeling	SUPPL	5	AP	2009-02-20
LABELING; Labeling	SUPPL	9	AP	2011-01-27
LABELING; Labeling	SUPPL	11	AP	2012-05-09	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-05-31	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-05-31	STANDARD

Submissions Property Types

SUPPL	11	Null	15
SUPPL	16	Null	7
SUPPL	20	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76796
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FUROSEMIDE","submission":"FUROSEMIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FUROSEMIDE","submission":"FUROSEMIDE","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FUROSEMIDE","submission":"FUROSEMIDE","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)