NDA 205555

NOVATECH SA

FDA Drug Application

Application #205555

Documents

• Label: 2017-05-04
• Letter: 2017-05-08
• Review: 2017-09-27

Application Sponsors

NDA 205555

NOVATECH SA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	POWDER;INTRAPLEURAL	2GM/VIAL	1	STERITALC	TALC
002	POWDER;INTRAPLEURAL	3GM/VIAL	1	STERITALC	TALC
003	POWDER;INTRAPLEURAL	4GM/VIAL	1	STERITALC	TALC

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2017-05-01

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

NOVATECH SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205555
            [companyName] => NOVATECH SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"STERITALC","activeIngredients":"TALC","strength":"2GM\/VIAL","dosageForm":"POWDER;INTRAPLEURAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"STERITALC","activeIngredients":"TALC","strength":"3GM\/VIAL","dosageForm":"POWDER;INTRAPLEURAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"STERITALC","activeIngredients":"TALC","strength":"4GM\/VIAL","dosageForm":"POWDER;INTRAPLEURAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/01\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205555s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/01\/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\\\/205555s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205555Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/205555Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-05-01
        )

)