NDA 017659

BOEHRINGER INGELHEIM

FDA Drug Application

Application #017659

Application Sponsors

NDA 017659

BOEHRINGER INGELHEIM

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

5%

0

ALUPENT

METAPROTERENOL SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1980-09-18	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1981-02-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1981-03-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1981-07-10	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1981-05-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1981-09-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-02-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-03-22	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1982-03-22	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1982-04-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-01-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-11-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1983-03-03	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1983-12-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1985-06-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1986-01-31	PRIORITY
LABELING; Labeling	SUPPL	19	AP	1986-01-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1986-01-31	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1986-01-31	PRIORITY
LABELING; Labeling	SUPPL	22	AP	1986-02-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1988-04-12	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1986-10-29	PRIORITY
EFFICACY; Efficacy	SUPPL	25	AP	1991-11-14	PRIORITY
LABELING; Labeling	SUPPL	26	AP	1991-11-14	PRIORITY
LABELING; Labeling	SUPPL	29	AP	1992-07-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1992-07-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1996-11-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1997-02-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1997-05-01	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	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	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17659
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALUPENT","activeIngredients":"METAPROTERENOL SULFATE","strength":"5%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALUPENT","submission":"METAPROTERENOL SULFATE","actionType":"5%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)