ANDA 210924

TEVA PHARMS USA INC

FDA Drug Application

Application #210924

Documents

• Letter: 2019-01-18

Application Sponsors

ANDA 210924

TEVA PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	8.6MG	0	METHYLPHENIDATE	METHYLPHENIDATE
002	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	17.3MG	0	METHYLPHENIDATE	METHYLPHENIDATE
003	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	25.9MG	0	METHYLPHENIDATE	METHYLPHENIDATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-12-20

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ACTAVIS ELIZABETH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210924
            [companyName] => ACTAVIS ELIZABETH
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE","activeIngredients":"METHYLPHENIDATE","strength":"8.6MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE","activeIngredients":"METHYLPHENIDATE","strength":"17.3MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE","activeIngredients":"METHYLPHENIDATE","strength":"25.9MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210924Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-19
        )

)