ANDA 040461

DR REDDYS LABS SA

FDA Drug Application

Application #040461

Documents

• Letter: 2004-02-27

Application Sponsors

ANDA 040461

DR REDDYS LABS SA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

MERCAPTOPURINE

MERCAPTOPURINE

FDA Submissions

	ORIG	1	AP	2004-02-11
LABELING; Labeling	SUPPL	2	AP	2005-05-18
LABELING; Labeling	SUPPL	6	AP	2013-03-08

Submissions Property Types

SUPPL

6

Null

15

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40461
            [companyName] => DR REDDYS LABS SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MERCAPTOPURINE","activeIngredients":"MERCAPTOPURINE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MERCAPTOPURINE","submission":"MERCAPTOPURINE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)