ANDA 078783

PAR PHARM INC

FDA Drug Application

Application #078783

Documents

• Letter: 2009-11-19
• Letter: 2009-07-15

Application Sponsors

ANDA 078783

PAR PHARM INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	100MG	0	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	200MG	0	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	300MG	0	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-11-13
LABELING; Labeling	SUPPL	4	AP	2017-08-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2017-08-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-08-29	STANDARD
REMS; REMS	SUPPL	8	AP	2018-09-18
LABELING; Labeling	SUPPL	9	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-10-09	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-09-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78783
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAMADOL HYDROCHLORIDE","submission":"TRAMADOL HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRAMADOL HYDROCHLORIDE","submission":"TRAMADOL HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRAMADOL HYDROCHLORIDE","submission":"TRAMADOL HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)