NDA 212593

American Regent, Inc.

FDA Drug Application

Application #212593

Documents

• Letter: 2020-01-29
• Label: 2020-08-04
• Review: 2021-05-17

Application Sponsors

NDA 212593

American Regent, Inc.

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;INTRAVENOUS

20UNITS/ML (20UNITS/ML)

0

VASOPRESSIN

VASOPRESSIN

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA

ORIG

1

TA

2020-01-28

STANDARD

Submissions Property Types

ORIG

1

Null

6

TE Codes

001

Prescription

TBD

CDER Filings

American Regent, Inc.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212593
            [companyName] => American Regent, Inc.
            [docInserts] => ["",""]
            [products] => [{"drugName":"VASOPRESSIN","activeIngredients":"VASOPRESSIN","strength":"20UNITS\/ML (20UNITS\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212593Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-28
        )

)