ANDA 087672

MYLAN PHARMS INC

FDA Drug Application

Application #087672

Application Sponsors

ANDA 087672

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

5MG

0

METHYCLOTHIAZIDE

METHYCLOTHIAZIDE

FDA Submissions

	ORIG	1	AP	1982-08-17
LABELING; Labeling	SUPPL	3	AP	1989-12-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-01-31
LABELING; Labeling	SUPPL	5	AP	1991-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-02-25

Submissions Property Types

SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87672
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYCLOTHIAZIDE","activeIngredients":"METHYCLOTHIAZIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYCLOTHIAZIDE","submission":"METHYCLOTHIAZIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)