ANDA 211774

SHILPA MEDICARE LTD

FDA Drug Application

Application #211774

Documents

• Letter: 2021-04-13

Application Sponsors

ANDA 211774

SHILPA MEDICARE LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	UNKNOWN	UNKNOWN	0	APREMILAST	APREMILAST
002	TABLET;ORAL	20MG	0	APREMILAST	APREMILAST
003	TABLET;ORAL	30MG	0	APREMILAST	APREMILAST

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-03-04

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SHILPA MEDICARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211774
            [companyName] => SHILPA MEDICARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-04
        )

)