ANDA 212416

CUSTOPHARM INC

FDA Drug Application

Application #212416

Documents

• Letter: 2021-06-15

Application Sponsors

ANDA 212416

CUSTOPHARM INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200 IU/ML

0

CALCITONIN-SALMON

CALCITONIN SALMON

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

CUSTOPHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212416
            [companyName] => CUSTOPHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCITONIN-SALMON","activeIngredients":"CALCITONIN SALMON","strength":"200 IU\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-14
        )

)