ANDA 206885

MACLEODS PHARMS LTD

FDA Drug Application

Application #206885

Application Sponsors

ANDA 206885

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

325MG;37.5MG

0

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-05-02	STANDARD
REMS; REMS	SUPPL	10	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	7
SUPPL	10	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206885
            [companyName] => MACLEODS PHARMS LTD
            [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":"05\/02\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-10","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)