ANDA 084927

IMPAX LABS

FDA Drug Application

Application #084927

Application Sponsors

ANDA 084927

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

METHOCARBAMOL

METHOCARBAMOL

FDA Submissions

	ORIG	1	AP	1976-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1983-12-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1983-12-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1986-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1986-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1987-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1988-04-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1987-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1987-11-10
LABELING; Labeling	SUPPL	30	AP	1988-12-22
LABELING; Labeling	SUPPL	31	AP	1989-01-25

Submissions Property Types

SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84927
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHOCARBAMOL","submission":"METHOCARBAMOL","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)