NDA 010374

3M

FDA Drug Application

Application #010374

Application Sponsors

NDA 010374

3M

Marketing Status

• Discontinued: 003

Application Products

003

AEROSOL, METERED;INHALATION

0.3MG/INH

0

MEDIHALER-EPI

EPINEPHRINE BITARTRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1956-03-09	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2009-03-13
LABELING; Labeling	SUPPL	6	AP	2009-03-13
LABELING; Labeling	SUPPL	8	AP	2009-03-13
LABELING; Labeling	SUPPL	11	AP	2009-03-13
LABELING; Labeling	SUPPL	12	AP	2009-03-13
LABELING; Labeling	SUPPL	13	AP	2009-03-13
LABELING; Labeling	SUPPL	14	AP	2009-03-13
LABELING; Labeling	SUPPL	18	AP	2009-03-13
LABELING; Labeling	SUPPL	20	AP	1992-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1989-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1994-01-14
LABELING; Labeling	SUPPL	25	AP	2009-03-13	STANDARD

Submissions Property Types

SUPPL	22	Null	0
SUPPL	24	Null	0

CDER Filings

3M

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10374
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEDIHALER-EPI","activeIngredients":"EPINEPHRINE BITARTRATE","strength":"0.3MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEDIHALER-EPI","submission":"EPINEPHRINE BITARTRATE","actionType":"0.3MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)