ANDA 088364

3M

FDA Drug Application

Application #088364

Application Sponsors

ANDA 088364

3M

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

300MG

0

THEOLAIR-SR

THEOPHYLLINE

FDA Submissions

	ORIG	1	AP	1987-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-01-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1991-01-15
LABELING; Labeling	SUPPL	6	AP	1991-02-15
LABELING; Labeling	SUPPL	8	AP	1998-05-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-12-03

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

CDER Filings

3M

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88364
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOLAIR-SR","activeIngredients":"THEOPHYLLINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEOLAIR-SR","submission":"THEOPHYLLINE","actionType":"300MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)