ANDA 211601

TEVA PHARMS USA INC

FDA Drug Application

Application #211601

Documents

• Letter: 2021-10-08

Application Sponsors

ANDA 211601

TEVA PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE; ORAL

20MG

0

TASIMELTEON

TASIMELTEON

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-09-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211601
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TASIMELTEON","activeIngredients":"TASIMELTEON","strength":"20MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211601Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-27
        )

)