ANDA 075168

DR REDDYS LABS INC

FDA Drug Application

Application #075168

Documents

• Letter: 1998-07-28

Application Sponsors

ANDA 075168

DR REDDYS LABS INC

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

220MG

0

NAPROXEN SODIUM

NAPROXEN SODIUM

FDA Submissions

	ORIG	1	AP	1998-07-28
LABELING; Labeling	SUPPL	5	AP	2008-03-16
LABELING; Labeling	SUPPL	8	AP	2009-07-10
LABELING; Labeling	SUPPL	11	AP	2010-12-13

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75168
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"220MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"220MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)