ANDA 200483

HIKMA

FDA Drug Application

Application #200483

Application Sponsors

ANDA 200483

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	150MG	0	CAPECITABINE	CAPECITABINE
002	TABLET;ORAL	500MG	0	CAPECITABINE	CAPECITABINE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2016-07-14
LABELING; Labeling	SUPPL	2	AP	2019-12-11	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-12-11	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-10-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-08-12	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200483
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAPECITABINE","activeIngredients":"CAPECITABINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPECITABINE","activeIngredients":"CAPECITABINE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/14\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/11\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/11\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-11
        )

)