ANDA 076914

CSPC OUYI

FDA Drug Application

Application #076914

Application Sponsors

ANDA 076914

CSPC OUYI

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

325MG;37.5MG

0

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2006-07-26
LABELING; Labeling	SUPPL	4	AP	2017-06-16	STANDARD
REMS; REMS	SUPPL	6	AP	2018-09-18

Submissions Property Types

SUPPL	4	Null	15
SUPPL	6	Null	15

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76914
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","strength":"325MG;37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","actionType":"325MG;37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)