Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 300MG;300MG | 0 | TEMIXYS | LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2018-11-16 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2019-10-29 | STANDARD |
Submissions Property Types
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
)
)