NDA 016402

BOEHRINGER INGELHEIM

FDA Drug Application

Application #016402

Application Sponsors

NDA 016402

BOEHRINGER INGELHEIM

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL, METERED;INHALATION

0.65MG/INH

0

ALUPENT

METAPROTERENOL SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1973-07-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1974-12-18	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1974-12-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1976-10-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1976-12-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1976-12-22	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1977-05-25	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1978-10-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1978-10-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1979-08-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1980-01-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1981-06-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1982-04-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1982-04-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1984-08-16	PRIORITY
LABELING; Labeling	SUPPL	20	AP	1984-08-16	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1984-08-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1985-05-17	PRIORITY
LABELING; Labeling	SUPPL	23	AP	1985-11-29	PRIORITY
LABELING; Labeling	SUPPL	25	AP	1986-06-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1986-10-09	PRIORITY
LABELING; Labeling	SUPPL	27	AP	1986-07-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1989-03-17	PRIORITY
LABELING; Labeling	SUPPL	29	AP	1989-03-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1989-03-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1989-12-07	PRIORITY
LABELING; Labeling	SUPPL	34	AP	1994-07-08	PRIORITY
LABELING; Labeling	SUPPL	35	AP	1997-07-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1997-11-26	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	37	Null	0

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16402
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALUPENT","activeIngredients":"METAPROTERENOL SULFATE","strength":"0.65MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALUPENT","submission":"METAPROTERENOL SULFATE","actionType":"0.65MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)