PAR STERILE PRODUCTS FDA Approval ANDA 209358

ANDA 209358

PAR STERILE PRODUCTS

FDA Drug Application

Application #209358

Application Sponsors

ANDA 209358PAR STERILE PRODUCTS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION200 IU/ML0CALCITONIN-SALMONCALCITONIN SALMON

FDA Submissions

UNKNOWN; ORIG1AP2021-11-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

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
        )

)

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