ANDA 209358

PAR STERILE PRODUCTS

FDA Drug Application

Application #209358

Application Sponsors

ANDA 209358

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200 IU/ML

0

CALCITONIN-SALMON

CALCITONIN SALMON

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-11-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209358
            [companyName] => PAR STERILE PRODUCTS
            [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":"11\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-10
        )

)