AMPHASTAR PHARMS INC FDA Approval ANDA 209832

ANDA 209832

AMPHASTAR PHARMS INC

FDA Drug Application

Application #209832

Application Sponsors

ANDA 209832AMPHASTAR PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION25MG/ML0SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-12-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

AMPHASTAR PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209832
            [companyName] => AMPHASTAR PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM NITROPRUSSIDE","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-18
        )

)

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