APPLICATION
NDA017659
TYPE
NDA
ORIGINAL APPROVAL
1980-09-18
LATEST ACTION
1997-05-01
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ALUPENTDiscontinued
METAPROTERENOL SULFATE 5% · SOLUTION · INHALATION
Approval history
1997-05-01Manufacturing (CMC) · Supplement 34 · priorityAP
1997-02-13Manufacturing (CMC) · Supplement 32 · priorityAP
1996-11-01Manufacturing (CMC) · Supplement 31 · priorityAP
1992-07-02Manufacturing (CMC) · Supplement 30 · priorityAP
1992-07-02Labeling · Supplement 29 · priorityAP
1991-11-14Labeling · Supplement 26 · priorityAP
1991-11-14Efficacy · Supplement 25 · priorityAP
1988-04-12Manufacturing (CMC) · Supplement 23 · priorityAP
1986-10-29Labeling · Supplement 24 · priorityAP
1986-02-14Labeling · Supplement 22 · priorityAP
1986-01-31Labeling · Supplement 21 · priorityAP
1986-01-31Manufacturing (CMC) · Supplement 18 · priorityAP
1986-01-31Manufacturing (CMC) · Supplement 20 · priorityAP
1986-01-31Labeling · Supplement 19 · priorityAP
1985-06-19Manufacturing (CMC) · Supplement 16 · priorityAP
1983-12-30Labeling · Supplement 15 · priorityAP
1983-03-03Manufacturing (CMC) · Supplement 14 · priorityAP
1983-01-05Manufacturing (CMC) · Supplement 11 · priorityAP
1982-11-05Manufacturing (CMC) · Supplement 12 · priorityAP
1982-04-30Labeling · Supplement 10 · priorityAP
1982-03-22Manufacturing (CMC) · Supplement 8 · priorityAP
1982-03-22Labeling · Supplement 9 · priorityAP
1982-02-12Manufacturing (CMC) · Supplement 7 · priorityAP
1981-09-11Manufacturing (CMC) · Supplement 6 · priorityAP
1981-07-10Manufacturing (CMC) · Supplement 4 · priorityAP
1981-05-12Labeling · Supplement 5 · priorityAP
1981-03-03Manufacturing (CMC) · Supplement 3 · priorityAP
1981-02-18Labeling · Supplement 2 · priorityAP
1981-01-16Labeling · Supplement 1 · priorityAP
1980-09-18Type 3 - New Dosage Form · 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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