ANDA 204920

MYLAN PHARMS INC

FDA Drug Application

Application #204920

Application Sponsors

ANDA 204920

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002

Application Products

001	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE;375MG	0	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN
002	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE;500MG	0	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-02-20

Submissions Property Types

ORIG

1

Null

17

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204920
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM; NAPROXEN","activeIngredients":"ESOMEPRAZOLE MAGNESIUM;NAPROXEN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/20\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-20
        )

)