ANDA 207564

NOVAST LABS

FDA Drug Application

Application #207564

Application Sponsors

ANDA 207564

NOVAST LABS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	CAPSULE;ORAL	67MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE
002	CAPSULE;ORAL	134MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE
003	CAPSULE;ORAL	200MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-06-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207564
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"67MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"134MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-19
        )

)