ANDA 077381

DR REDDYS LABS INC

FDA Drug Application

Application #077381

Documents

• Other Important Information from FDA: 2006-10-10
• Healthcare Professional Sheet: 2006-10-10

Application Sponsors

ANDA 077381

DR REDDYS LABS INC

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

220MG;120MG

0

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-09-27
LABELING; Labeling	SUPPL	3	AP	2011-05-24
LABELING; Labeling	SUPPL	6	AP	2015-05-04

Submissions Property Types

SUPPL

6

Null

15

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77381
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"220MG;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE","submission":"NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"220MG;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)