ANDA 090061

HETERO LABS LTD III

FDA Drug Application

Application #090061

Application Sponsors

ANDA 090061

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

FINASTERIDE

FINASTERIDE

FDA Submissions

	ORIG	1	AP	2010-06-07
LABELING; Labeling	SUPPL	3	AP	2012-02-14
LABELING; Labeling	SUPPL	5	AP	2013-02-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2013-04-26	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-04-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2015-04-06	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2015-03-19	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2022-03-11	STANDARD
LABELING; Labeling	SUPPL	18	AP	2022-03-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	17	Null	15
SUPPL	18	Null	15

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90061
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINASTERIDE","activeIngredients":"FINASTERIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FINASTERIDE","submission":"FINASTERIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)