ANDA 209801

TEVA PHARMS USA INC

FDA Drug Application

Application #209801

Documents

• Letter: 2018-02-09
• Letter: 2022-08-30

Application Sponsors

ANDA 209801

TEVA PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 006

Application Products

001	TABLET;ORAL	2MG	0	PERAMPANEL	PERAMPANEL
002	TABLET;ORAL	4MG	0	PERAMPANEL	PERAMPANEL
003	TABLET;ORAL	6MG	0	PERAMPANEL	PERAMPANEL
004	TABLET;ORAL	8MG	0	PERAMPANEL	PERAMPANEL
005	TABLET;ORAL	10MG	0	PERAMPANEL	PERAMPANEL
006	TABLET;ORAL	12MG	0	PERAMPANEL	PERAMPANEL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-01-17

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209801
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"12MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/17\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209801Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-01-17
        )

)