NDA 211875

HBT LABS INC

FDA Drug Application

Application #211875

Documents

• Letter: 2021-07-01
• Label: 2022-07-28

Application Sponsors

NDA 211875

HBT LABS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

VIAL

100MG

0

PACLITAXEL

PACLITAXEL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2021-06-30

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

HBT LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211875
            [companyName] => HBT LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PACLITAXEL","activeIngredients":"PACLITAXEL","strength":"100MG","dosageForm":"VIAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/30\/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\\\/211875Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-30
        )

)