ANDA 215537

MICRO LABS

FDA Drug Application

Application #215537

Application Sponsors

ANDA 215537

MICRO LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

800MG

0

SEVELAMER CARBONATE

SEVELAMER CARBONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215537
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-07
        )

)