NDA 017571

BOEHRINGER INGELHEIM

FDA Drug Application

Application #017571

Application Sponsors

NDA 017571

BOEHRINGER INGELHEIM

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

10MG/5ML

0

ALUPENT

METAPROTERENOL SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1975-05-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1976-11-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1976-11-01	STANDARD
LABELING; Labeling	SUPPL	5	AP	1976-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1976-11-01	STANDARD
LABELING; Labeling	SUPPL	7	AP	2002-11-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1979-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1979-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1980-01-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1981-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1981-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1982-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1982-03-22	STANDARD
LABELING; Labeling	SUPPL	17	AP	1982-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1983-01-05	STANDARD
LABELING; Labeling	SUPPL	19	AP	1983-11-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1985-06-20	STANDARD
LABELING; Labeling	SUPPL	21	AP	1984-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1985-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1985-05-28	STANDARD
LABELING; Labeling	SUPPL	24	AP	1985-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1986-06-05	STANDARD
LABELING; Labeling	SUPPL	27	AP	1986-06-05
LABELING; Labeling	SUPPL	28	AP	1986-10-29
LABELING; Labeling	SUPPL	30	AP	1992-04-29
LABELING; Labeling	SUPPL	32	AP	1991-10-15
LABELING; Labeling	SUPPL	33	AP	2002-11-12	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	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	18	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	26	Null	0

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17571
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALUPENT","activeIngredients":"METAPROTERENOL SULFATE","strength":"10MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALUPENT","submission":"METAPROTERENOL SULFATE","actionType":"10MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)