ANDA 206254

FRESENIUS KABI USA

FDA Drug Application

Application #206254

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 206254

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

10MG/VIAL

0

ROMIDEPSIN

ROMIDEPSIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206254
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROMIDEPSIN","activeIngredients":"ROMIDEPSIN","strength":"10MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-12
        )

)