ANDA 212490

ALKEM LABS LTD

FDA Drug Application

Application #212490

Documents

• Letter: 2021-08-16

Application Sponsors

ANDA 212490

ALKEM LABS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	250MCG	0	ROFLUMILAST	ROFLUMILAST
002	TABLET;ORAL	500MCG	0	ROFLUMILAST	ROFLUMILAST

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-06-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212490
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROFLUMILAST","activeIngredients":"ROFLUMILAST","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-21
        )

)