G1 THERAPEUTICS INC FDA Approval NDA 214200

NDA 214200

G1 THERAPEUTICS INC

FDA Drug Application

Application #214200

Documents

Label2021-02-16

Application Sponsors

NDA 214200G1 THERAPEUTICS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION300MG2COSELATRILACICLIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-02-12STANDARD

Submissions Property Types

ORIG1Null30

TE Codes

001PrescriptionTBD

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
        )

)

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