ANDA 090619

DR REDDYS LABS LTD

FDA Drug Application

Application #090619

Documents

• Review: 2012-01-27

Application Sponsors

ANDA 090619

DR REDDYS LABS LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

38MG;200MG

0

IBUPROFEN AND DIPHENHYDRAMINE CITRATE

DIPHENHYDRAMINE CITRATE; IBUPROFEN

FDA Submissions

	ORIG	1	AP	2009-07-08
LABELING; Labeling	SUPPL	3	AP	2015-01-20

Submissions Property Types

SUPPL

3

Null

15

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90619
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN AND DIPHENHYDRAMINE CITRATE","activeIngredients":"DIPHENHYDRAMINE CITRATE; IBUPROFEN","strength":"38MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN AND DIPHENHYDRAMINE CITRATE","submission":"DIPHENHYDRAMINE CITRATE; IBUPROFEN","actionType":"38MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)