ACTAVIS LABS FL INC FDA Approval ANDA 204470

ANDA 204470

ACTAVIS LABS FL INC

FDA Drug Application

Application #204470

Application Sponsors

ANDA 204470ACTAVIS LABS FL INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, DELAYED RELEASE;ORALEQ 20MG BASE;375MG0NAPROXEN AND ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM; NAPROXEN
002TABLET, DELAYED RELEASE;ORALEQ 20MG BASE;500MG0NAPROXEN AND ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM; NAPROXEN

FDA Submissions

UNKNOWN; ORIG1AP2022-08-24STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

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
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.