ANDA 090060

HETERO LABS LTD III

FDA Drug Application

Application #090060

Application Sponsors

ANDA 090060

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1MG

0

FINASTERIDE

FINASTERIDE

FDA Submissions

	ORIG	1	AP	2013-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2016-11-22	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2022-05-05	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90060
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINASTERIDE","activeIngredients":"FINASTERIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FINASTERIDE","submission":"FINASTERIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)