NDA 215441

INTAS PHARMS USA

FDA Drug Application

Application #215441

Documents

• Letter: 2021-08-24
• Label: 2022-07-27

Application Sponsors

NDA 215441

INTAS PHARMS USA

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	2.5MG/ML (2.5MG/ML)	1	BORTEZOMIB	BORTEZOMIB
002	SOLUTION;INTRAVENOUS	3.5MG/1.4ML (2.5MG/ML)	1	BORTEZOMIB	BORTEZOMIB

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2021-08-20

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

INTAS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215441
            [companyName] => INTAS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/20\/2021","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\\\/2021\\\/215441Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-20
        )

)