BLA 761255

FRESENIUS KABI USA

FDA Drug Application

Application #761255

Documents

• Label: 2022-12-14
• Letter: 2022-12-15

Application Sponsors

BLA 761255

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

40MG/0.8ML

0

IDACIO

ADALIMUMAB-AACF

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2022-12-13

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761255
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IDACIO","activeIngredients":"ADALIMUMAB-AACF","strength":"40MG\/0.8ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/13\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761255s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761255s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761255Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-12-13
        )

)