NDA 210326

FRESENIUS KABI USA

FDA Drug Application

Application #210326

Documents

• Letter: 2019-10-22
• Label: 2019-05-21
• Review: 2020-02-04
• Letter: 2021-05-13
• Letter: 2021-05-13
• Label: 2021-05-13
• Label: 2021-05-13

Application Sponsors

NDA 210326

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR

250MG/5ML (50MG/ML)

0

FULVESTRANT

FULVESTRANT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2019-05-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-05-12	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	6

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210326
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVESTRANT","activeIngredients":"FULVESTRANT","strength":"250MG\/5ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/20\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210326s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210326s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210326Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/210326Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-05-20
        )

)