ANDA 209499

DR REDDYS

FDA Drug Application

Application #209499

Documents

• Letter: 2022-08-30

Application Sponsors

ANDA 209499

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

1GM

0

ICOSAPENT ETHYL

ICOSAPENT ETHYL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-08-07	STANDARD
UNKNOWN;	ORIG	2	TA	2020-08-07	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	31

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209499
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ICOSAPENT ETHYL","activeIngredients":"ICOSAPENT ETHYL","strength":"1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/07\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-07
        )

)