TG THERAPEUTICS INC FDA Approval NDA 213176

NDA 213176

TG THERAPEUTICS INC

FDA Drug Application

Application #213176

Documents

Label2021-02-05
Label2021-02-05
Medication Guide2021-02-05
Letter2021-02-09
Letter2021-02-09

Application Sponsors

NDA 213176TG THERAPEUTICS INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL200MG2UKONIQUMBRALISIB TOSYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-02-05PRIORITY
TYPE 1; Type 1 - New Molecular EntityORIG2AP2021-02-05PRIORITY

Submissions Property Types

ORIG1Null30
ORIG2Null6

CDER Filings

TG THERAPEUTICS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213176
            [companyName] => TG THERAPEUTICS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/213176s000lbl.pdf#page=19"]
            [products] => [{"drugName":"UKONIQ","activeIngredients":"UMBRALISIB TOSYLATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/05\/2021","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213176s000lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213176s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/05\/2021","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213176s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"02\/05\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213176s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-02-05
        )

)

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