ANDA 086363

3M

FDA Drug Application

Application #086363

Application Sponsors

ANDA 086363

3M

Marketing Status

• Discontinued: 002

Application Products

002

TABLET, EXTENDED RELEASE;ORAL

250MG

0

THEOLAIR-SR

THEOPHYLLINE

FDA Submissions

	ORIG	1	AP	1987-07-16
LABELING; Labeling	SUPPL	3	AP	1990-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-02-05
LABELING; Labeling	SUPPL	10	AP	1990-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-12-03

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0

CDER Filings

3M

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86363
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOLAIR-SR","activeIngredients":"THEOPHYLLINE","strength":"250MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEOLAIR-SR","submission":"THEOPHYLLINE","actionType":"250MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)