ANDA 211857

AMPHASTAR PHARMS INC

FDA Drug Application

Application #211857

Documents

• Letter: 2022-01-12

Application Sponsors

ANDA 211857

AMPHASTAR PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

20 Units/mL

0

VASOPRESSIN

VASOPRESSIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-12-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

AMPHASTAR PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211857
            [companyName] => AMPHASTAR PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VASOPRESSIN","activeIngredients":"VASOPRESSIN","strength":"20 Units\/mL","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/211857Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-28
        )

)