ANDA 213000

VISTAPHARM

FDA Drug Application

Application #213000

Documents

• Letter: 2019-12-03

Application Sponsors

ANDA 213000

VISTAPHARM

Marketing Status

• Prescription: 001

Application Products

001

ELIXIR;ORAL

0.05MG/ML

0

DIGOXIN

DIGOXIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-10-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213000
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.05MG\/ML","dosageForm":"ELIXIR;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/213000Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-04
        )

)