ANDA 203808

EDENBRIDGE PHARMS

FDA Drug Application

Application #203808

Application Sponsors

ANDA 203808

EDENBRIDGE PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-08-04
LABELING; Labeling	SUPPL	4	AP	2022-07-25	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	4	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

EDENBRIDGE PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203808
            [companyName] => EDENBRIDGE PHARMS
            [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":"08\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-08-04
        )

)