BLA 761173

FRESENIUS KABI USA

FDA Drug Application

Application #761173

Documents

• Letter: 2022-09-02
• Label: 2022-09-02
• Review: 2022-11-16

Application Sponsors

BLA 761173

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; INJECTION

6MG/0.6ML

0

STIMUFEND

PEGFILGRASTIM-FPGK

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

FRESENIUS KABI USA

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(
    [0] => Array
        (
            [ApplNo] => 761173
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"STIMUFEND","activeIngredients":"PEGFILGRASTIM-FPGK","strength":"6MG\/0.6ML","dosageForm":"SOLUTION; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/01\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761173s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/01\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761173s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761173Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-01
        )

)