CELLTRION FDA Approval NDA 211284

NDA 211284

CELLTRION

FDA Drug Application

Application #211284

Documents

Label2018-11-20
Letter2018-11-20
Review2018-12-17
Letter2019-04-12
Letter2019-10-30
Label2019-10-30
Pediatric DD Summary Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01

Application Sponsors

NDA 211284CELLTRION

Marketing Status

Prescription001

Application Products

001TABLET;ORAL300MG;300MG0TEMIXYSLAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2018-11-16STANDARD
LABELING; LabelingSUPPL2AP2019-10-29STANDARD

Submissions Property Types

ORIG1Null40
SUPPL2Null7

CDER Filings

CELLTRION
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211284
            [companyName] => CELLTRION
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMIXYS","activeIngredients":"LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"300MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/29\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211284s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211284s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211284s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211284s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211284s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211284Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/211284Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/29\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211284s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211284Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"04\/10\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211284Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-29
        )

)

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