ANDA 214363

NAVINTA LLC

FDA Drug Application

Application #214363

Application Sponsors

ANDA 214363

NAVINTA LLC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

PENICILLAMINE

PENICILLAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

NAVINTA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214363
            [companyName] => NAVINTA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENICILLAMINE","activeIngredients":"PENICILLAMINE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/08\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-08
        )

)