APPLICATION
NDA016402
TYPE
NDA
ORIGINAL APPROVAL
1973-07-31
LATEST ACTION
1997-11-26
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
ALUPENTDiscontinued
METAPROTERENOL SULFATE 0.65MG/INH · AEROSOL, METERED · INHALATION
Approval history
1997-11-26Manufacturing (CMC) · Supplement 37 · priorityAP
1997-07-16Labeling · Supplement 35 · priorityAP
1994-07-08Labeling · Supplement 34 · priorityAP
1989-12-07Manufacturing (CMC) · Supplement 33 · priorityAP
1989-03-17Manufacturing (CMC) · Supplement 30 · priorityAP
1989-03-17Labeling · Supplement 29 · priorityAP
1989-03-17Manufacturing (CMC) · Supplement 28 · priorityAP
1986-10-09Manufacturing (CMC) · Supplement 26 · priorityAP
1986-07-24Labeling · Supplement 27 · priorityAP
1986-06-04Labeling · Supplement 25 · priorityAP
1985-11-29Labeling · Supplement 23 · priorityAP
1985-05-17Manufacturing (CMC) · Supplement 22 · priorityAP
1984-08-21Labeling · Supplement 21 · priorityAP
1984-08-16Labeling · Supplement 20 · priorityAP
1984-08-16Manufacturing (CMC) · Supplement 19 · priorityAP
1982-04-01Manufacturing (CMC) · Supplement 18 · priorityAP
1982-04-01Manufacturing (CMC) · Supplement 17 · priorityAP
1981-06-24Manufacturing (CMC) · Supplement 16 · priorityAP
1980-01-04Manufacturing (CMC) · Supplement 15 · priorityAP
1979-08-01Manufacturing (CMC) · Supplement 14 · priorityAP
1978-10-20Labeling · Supplement 12 · priorityAP
1978-10-13Manufacturing (CMC) · Supplement 13 · priorityAP
1977-05-25Labeling · Supplement 11 · priorityAP
1976-12-22Manufacturing (CMC) · Supplement 10 · priorityAP
1976-12-22Manufacturing (CMC) · Supplement 9 · priorityAP
1976-10-07Manufacturing (CMC) · Supplement 7 · priorityAP
1974-12-18Labeling · Supplement 6 · priorityAP
1974-12-18Manufacturing (CMC) · Supplement 2 · priorityAP
1973-07-31Type 1 - New Molecular Entity · Original · priorityAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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