ANDA 212086

FRESENIUS KABI USA

FDA Drug Application

Application #212086

Application Sponsors

ANDA 212086

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.05MG BASE/ML

0

FENTANYL CITRATE

FENTANYL CITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212086
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENTANYL CITRATE","activeIngredients":"FENTANYL CITRATE","strength":"EQ 0.05MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-01
        )

)