NDA 210063

TEVA PHARMS USA INC

FDA Drug Application

Application #210063

Documents

• Label: 2019-08-20
• Letter: 2019-08-20
• Review: 2020-03-12
• Letter: 2021-04-07
• Label: 2021-04-12
• Letter: 2021-11-15
• Label: 2021-11-15

Application Sponsors

NDA 210063

TEVA PHARMS USA INC

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	2019-08-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-04-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-11-12	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	31
SUPPL	3	Null	7

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210063
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVESTRANT","activeIngredients":"FULVESTRANT","strength":"250MG\/5ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/19\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210063s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/19\/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\\\/2019\\\/210063s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210063Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/210063Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-08-19
        )

)