ANDA 204470

ACTAVIS LABS FL INC

FDA Drug Application

Application #204470

Application Sponsors

ANDA 204470

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 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

AP

2022-08-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204470
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN AND ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM; NAPROXEN","strength":"EQ 20MG BASE;375MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN AND ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM; NAPROXEN","strength":"EQ 20MG BASE;500MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-24
        )

)