ANDA 213720

ALKEM LABS LTD

FDA Drug Application

Application #213720

Application Sponsors

ANDA 213720

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE
002	TABLET;ORAL	10MG	0	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213720
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-27
        )

)