NDA 010375

3M

FDA Drug Application

Application #010375

Application Sponsors

NDA 010375

3M

Marketing Status

• Discontinued: 003
• Discontinued: 004

Application Products

003	AEROSOL, METERED;INHALATION	0.08MG/INH	0	MEDIHALER-ISO	ISOPROTERENOL SULFATE
004	AEROSOL, METERED;INHALATION	0.12MG/INH	0	ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1956-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1975-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1975-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1975-07-29	STANDARD
LABELING; Labeling	SUPPL	14	AP	1976-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1978-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1978-09-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1982-03-05	STANDARD
LABELING; Labeling	SUPPL	20	AP	1987-02-17
LABELING; Labeling	SUPPL	21	AP	1987-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1993-12-20	STANDARD
LABELING; Labeling	SUPPL	23	AP	1997-12-30	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	22	Null	0

CDER Filings

3M

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10375
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOPROTERENOL HYDROCHLORIDE","activeIngredients":"ISOPROTERENOL HYDROCHLORIDE","strength":"0.12MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MEDIHALER-ISO","activeIngredients":"ISOPROTERENOL SULFATE","strength":"0.08MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOPROTERENOL HYDROCHLORIDE","submission":"ISOPROTERENOL HYDROCHLORIDE","actionType":"0.12MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MEDIHALER-ISO","submission":"ISOPROTERENOL SULFATE","actionType":"0.08MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)