ANDA 211353

TEVA PHARMS USA INC

FDA Drug Application

Application #211353

Documents

• Letter: 2022-02-04

Application Sponsors

ANDA 211353

TEVA PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

400MG

0

SOFOSBUVIR

SOFOSBUVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211353
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOFOSBUVIR","activeIngredients":"SOFOSBUVIR","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-27
        )

)