ANDA 079234

HETERO LABS LTD III

FDA Drug Application

Application #079234

Application Sponsors

ANDA 079234

HETERO LABS LTD III

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	5MG	0	TORSEMIDE	TORSEMIDE
002	TABLET;ORAL	10MG	0	TORSEMIDE	TORSEMIDE
003	TABLET;ORAL	20MG	0	TORSEMIDE	TORSEMIDE
004	TABLET;ORAL	100MG	0	TORSEMIDE	TORSEMIDE

FDA Submissions

	ORIG	1	AP	2009-01-27
LABELING; Labeling	SUPPL	3	AP	2013-01-07	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	3	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79234
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TORSEMIDE","activeIngredients":"TORSEMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TORSEMIDE","submission":"TORSEMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)