ANDA 086445

MYLAN PHARMS INC

FDA Drug Application

Application #086445

Application Sponsors

ANDA 086445

MYLAN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG

0

TOLBUTAMIDE

TOLBUTAMIDE

FDA Submissions

	ORIG	1	AP	1979-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1982-03-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1984-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1987-08-28
LABELING; Labeling	SUPPL	52	AP	1989-08-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1990-01-31
LABELING; Labeling	SUPPL	54	AP	1991-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1993-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1998-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1998-02-05
LABELING; Labeling	SUPPL	59	AP	2001-09-27
LABELING; Labeling	SUPPL	63	AP	2009-11-12

Submissions Property Types

SUPPL	43	Null	0
SUPPL	45	Null	0
SUPPL	51	Null	0
SUPPL	53	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	63	Null	7

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86445
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLBUTAMIDE","activeIngredients":"TOLBUTAMIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOLBUTAMIDE","submission":"TOLBUTAMIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)