ANDA 205197

TEVA PHARMS USA

FDA Drug Application

Application #205197

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 205197

TEVA PHARMS USA

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-04-20

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205197
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PLERIXAFOR","activeIngredients":"PLERIXAFOR","strength":"24MG\/1.2ML (20MG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/20\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-20
        )

)