ANDA 201172

HIKMA

FDA Drug Application

Application #201172

Application Sponsors

ANDA 201172

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	250MG	0	TINIDAZOLE	TINIDAZOLE
002	TABLET;ORAL	500MG	0	TINIDAZOLE	TINIDAZOLE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-04-30
LABELING; Labeling	SUPPL	2	AP	2020-05-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-06-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201172
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TINIDAZOLE","activeIngredients":"TINIDAZOLE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TINIDAZOLE","activeIngredients":"TINIDAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/30\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-26
        )

)