ANDA 215209

AMICI

FDA Drug Application

Application #215209

Application Sponsors

ANDA 215209

AMICI

Marketing Status

• Prescription: 001

Application Products

001

ELIXIR;ORAL

0.05MG/ML

0

DIGOXIN

DIGOXIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

AMICI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215209
            [companyName] => AMICI
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIGOXIN","activeIngredients":"DIGOXIN","strength":"0.05MG\/ML","dosageForm":"ELIXIR;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-11
        )

)