NDA 020617

AVENT

FDA Drug Application

Application #020617

Application Sponsors

NDA 020617

AVENT

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	1uCi	1	PYTEST	UREA, C-14
002	CAPSULE;ORAL	1uCi	1	PYTEST KIT	UREA, C-14

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1997-05-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2014-01-31	N/A

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	6

CDER Filings

AVENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20617
            [companyName] => AVENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYTEST","activeIngredients":"UREA, C-14","strength":"1uCi","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PYTEST KIT","activeIngredients":"UREA, C-14","strength":"1uCi","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PYTEST","submission":"UREA, C-14","actionType":"1uCi","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PYTEST KIT","submission":"UREA, C-14","actionType":"1uCi","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)