ANDA 212458

PERRIGO UK FINCO

FDA Drug Application

Application #212458

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 212458

PERRIGO UK FINCO

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.5MG/SPRAY

0

CYANOCOBALAMIN

CYANOCOBALAMIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212458
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYANOCOBALAMIN","activeIngredients":"CYANOCOBALAMIN","strength":"0.5MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-09
        )

)