NDA 015874

BOEHRINGER INGELHEIM

FDA Drug Application

Application #015874

Application Sponsors

NDA 015874

BOEHRINGER INGELHEIM

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	20MG	0	ALUPENT	METAPROTERENOL SULFATE
002	TABLET;ORAL	10MG	0	ALUPENT	METAPROTERENOL SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1974-05-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1974-12-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1974-12-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1974-12-19	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1976-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1976-03-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1976-07-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1976-04-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1976-07-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1976-07-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1977-08-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1976-11-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1976-11-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1976-12-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1976-10-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1980-05-05	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1977-08-08
LABELING; Labeling	SUPPL	19	AP	1978-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1979-06-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1980-01-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1980-09-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1981-04-07	PRIORITY
LABELING; Labeling	SUPPL	24	AP	2002-11-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1981-06-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1982-02-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1983-05-05	PRIORITY
LABELING; Labeling	SUPPL	28	AP	1983-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1983-01-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1985-12-10	PRIORITY
LABELING; Labeling	SUPPL	31	AP	1983-11-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1985-12-10	PRIORITY
LABELING; Labeling	SUPPL	33	AP	1984-05-04
LABELING; Labeling	SUPPL	34	AP	1986-02-14
LABELING; Labeling	SUPPL	35	AP	1992-04-28
LABELING; Labeling	SUPPL	36	AP	1991-03-11
LABELING; Labeling	SUPPL	37	AP	2002-11-12	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	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	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	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	29	Null	0
SUPPL	30	Null	0
SUPPL	32	Null	0

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 15874
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALUPENT","activeIngredients":"METAPROTERENOL SULFATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ALUPENT","activeIngredients":"METAPROTERENOL SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALUPENT","submission":"METAPROTERENOL SULFATE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ALUPENT","submission":"METAPROTERENOL SULFATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)