ANDA 215472

STRIDES PHARMA

FDA Drug Application

Application #215472

Application Sponsors

ANDA 215472

STRIDES PHARMA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

EQ 200MG BASE

0

NAPROXEN SODIUM

NAPROXEN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-06-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215472
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"220MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-27
        )

)