NDA 013296

3M

FDA Drug Application

Application #013296

Application Sponsors

NDA 013296

3M

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL, METERED;INHALATION

0.16MG/INH;0.24MG/INH

0

DUO-MEDIHALER

ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1973-08-20	STANDARD
LABELING; Labeling	SUPPL	8	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-03-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-05-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	1987-02-27
LABELING; Labeling	SUPPL	13	AP	1994-02-23	STANDARD

Submissions Property Types

SUPPL	9	Null	0
SUPPL	10	Null	0

CDER Filings

3M

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13296
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUO-MEDIHALER","activeIngredients":"ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE","strength":"0.16MG\/INH;0.24MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DUO-MEDIHALER","submission":"ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE","actionType":"0.16MG\/INH;0.24MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)