ANDA 086989

PRINSTON INC

FDA Drug Application

Application #086989

Application Sponsors

ANDA 086989

PRINSTON INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG

0

METHOCARBAMOL

METHOCARBAMOL

FDA Submissions

	ORIG	1	AP	1979-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-11-08

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

TE Codes

001

Prescription

AA

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86989
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHOCARBAMOL","submission":"METHOCARBAMOL","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)