ANDA 077293

LEADING PHARMA LLC

FDA Drug Application

Application #077293

Application Sponsors

ANDA 077293

LEADING PHARMA LLC

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	2005-11-09
LABELING; Labeling	SUPPL	3	AP	2007-06-29
LABELING; Labeling	SUPPL	4	AP	2016-05-12
LABELING; Labeling	SUPPL	8	AP	2016-05-12	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

LEADING PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77293
            [companyName] => LEADING PHARMA LLC
            [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
        )

)