ANDA 209898

INDOCO

FDA Drug Application

Application #209898

Application Sponsors

ANDA 209898

INDOCO

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	2.5MG	0	APIXABAN	APIXABAN
002	TABLET;ORAL	5MG	0	APIXABAN	APIXABAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-09-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-06-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

INDOCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209898
            [companyName] => INDOCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-14
        )

)