ANDA 075982

PLIVA

FDA Drug Application

Application #075982

Application Sponsors

ANDA 075982

PLIVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2008-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2008-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2008-03-12
REMS; REMS	SUPPL	14	AP	2018-09-18

Submissions Property Types

SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	7

TE Codes

001

Prescription

AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75982
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAMADOL HYDROCHLORIDE","submission":"TRAMADOL HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)