ANDA 214753

ALKEM LABS LTD

FDA Drug Application

Application #214753

Application Sponsors

ANDA 214753

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	0.5MG	0	SIROLIMUS	SIROLIMUS
002	TABLET;ORAL	1MG	0	SIROLIMUS	SIROLIMUS
003	TABLET;ORAL	2MG	0	SIROLIMUS	SIROLIMUS

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-03-12

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214753
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-12
        )

)