ANDA 212449

DR REDDYS

FDA Drug Application

Application #212449

Application Sponsors

ANDA 212449

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 84MG BASE

0

ELIGLUSTAT TARTRATE

ELIGLUSTAT TARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212449
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELIGLUSTAT TARTRATE","activeIngredients":"ELIGLUSTAT TARTRATE","strength":"EQ 84MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-17
        )

)