NDA 208264

ADIENNE SA

FDA Drug Application

Application #208264

Documents

• Label: 2017-01-26
• Letter: 2017-01-30
• Review: 2018-07-06
• Letter: 2019-12-31

Application Sponsors

NDA 208264

ADIENNE SA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;INTRAVENOUS	15MG/VIAL	1	TEPADINA	THIOTEPA
002	POWDER;INTRAVENOUS	100MG/VIAL	1	TEPADINA	THIOTEPA

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2017-01-26

STANDARD

Submissions Property Types

ORIG

1

Null

6

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

ADIENNE SA

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(
    [0] => Array
        (
            [ApplNo] => 208264
            [companyName] => ADIENNE SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEPADINA","activeIngredients":"THIOTEPA","strength":"15MG\/VIAL","dosageForm":"POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TEPADINA","activeIngredients":"THIOTEPA","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/26\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208264s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208264s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208264Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208264Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/27\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208264Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-27
        )

)