ANDA 208687

ALKEM LABS LTD

FDA Drug Application

Application #208687

Application Sponsors

ANDA 208687

ALKEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	25MG	0	AZATHIOPRINE	AZATHIOPRINE
002	TABLET;ORAL	50MG	0	AZATHIOPRINE	AZATHIOPRINE
003	TABLET;ORAL	75MG	0	AZATHIOPRINE	AZATHIOPRINE
004	TABLET;ORAL	100MG	0	AZATHIOPRINE	AZATHIOPRINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208687
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZATHIOPRINE","activeIngredients":"AZATHIOPRINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AZATHIOPRINE","activeIngredients":"AZATHIOPRINE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AZATHIOPRINE","activeIngredients":"AZATHIOPRINE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AZATHIOPRINE","activeIngredients":"AZATHIOPRINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-27
        )

)