ANDA 076436

DR REDDYS LABS INC

FDA Drug Application

Application #076436

Documents

• Letter: 2006-08-04

Application Sponsors

ANDA 076436

DR REDDYS LABS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1MG

0

FINASTERIDE

FINASTERIDE

FDA Submissions

	ORIG	1	AP	2006-07-28
LABELING; Labeling	SUPPL	2	AP	2011-08-11
LABELING; Labeling	SUPPL	3	AP	2011-08-25
LABELING; Labeling	SUPPL	4	AP	2011-09-27
LABELING; Labeling	SUPPL	6	AP	2012-09-28	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-09-21	STANDARD

Submissions Property Types

SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	15

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76436
            [companyName] => DR REDDYS LABS INC
            [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
        )

)