ANDA 210705

AJANTA PHARMA LTD

FDA Drug Application

Application #210705

Application Sponsors

ANDA 210705

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 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	2018-09-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-06-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	14	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210705
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"67MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"134MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/15\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-15
        )

)