ANDA 090859

DR REDDYS LABS SA

FDA Drug Application

Application #090859

Application Sponsors

ANDA 090859

DR REDDYS LABS SA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	43MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE
002	CAPSULE;ORAL	130MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE

FDA Submissions

	ORIG	1	AP	2012-03-01
LABELING; Labeling	SUPPL	2	AP	2015-08-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

DR REDDYS LABS SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90859
            [companyName] => DR REDDYS LABS SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"43MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"130MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FENOFIBRATE (MICRONIZED)","submission":"FENOFIBRATE","actionType":"43MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENOFIBRATE (MICRONIZED)","submission":"FENOFIBRATE","actionType":"130MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)