NDA 214200

G1 THERAPEUTICS INC

FDA Drug Application

Application #214200

Documents

• Label: 2021-02-16
• Letter: 2021-03-08
• Review: 2021-03-12

Application Sponsors

NDA 214200

G1 THERAPEUTICS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

300MG

2

COSELA

TRILACICLIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-02-12

STANDARD

Submissions Property Types

ORIG

1

Null

30

TE Codes

001

Prescription

TBD

CDER Filings

G1 THERAPEUTICS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214200
            [companyName] => G1 THERAPEUTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"COSELA","activeIngredients":"TRILACICLIB","strength":"300MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/12\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214200s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214200s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-02-12
        )

)