NDA 213176

TG THERAPEUTICS INC

FDA Drug Application

Application #213176

Documents

• Label: 2021-02-05
• Label: 2021-02-05
• Medication Guide: 2021-02-05
• Letter: 2021-02-09
• Letter: 2021-02-09
• Review: 2021-03-05

Application Sponsors

NDA 213176

TG THERAPEUTICS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

2

UKONIQ

UMBRALISIB TOSYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-02-05	PRIORITY
TYPE 1; Type 1 - New Molecular Entity	ORIG	2	AP	2021-02-05	PRIORITY

Submissions Property Types

ORIG	1	Null	30
ORIG	2	Null	6

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
        )

)