NDA 216338

TEVA PHARMS

FDA Drug Application

Application #216338

Documents

• Letter: 2022-07-18

Application Sponsors

NDA 216338

TEVA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG

0

PACLITAXEL

PACLITAXEL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2022-07-15

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

TEVA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216338
            [companyName] => TEVA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PACLITAXEL","activeIngredients":"PACLITAXEL","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/15\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216338Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-15
        )

)