APPLICATION
NDA017571
TYPE
NDA
ORIGINAL APPROVAL
1975-05-23
LATEST ACTION
2002-11-12
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
ALUPENTDiscontinued
METAPROTERENOL SULFATE 10MG/5ML · SYRUP · ORAL
Approval history
2002-11-12Labeling · Supplement 7AP
2002-11-12Labeling · Supplement 33 · standardAP
1992-04-29Labeling · Supplement 30AP
1991-10-15Labeling · Supplement 32AP
1986-10-29Labeling · Supplement 28AP
1986-06-05Manufacturing (CMC) · Supplement 26 · standardAP
1986-06-05Labeling · Supplement 27AP
1985-06-20Manufacturing (CMC) · Supplement 22 · standardAP
1985-06-20Manufacturing (CMC) · Supplement 20 · standardAP
1985-05-28Labeling · Supplement 24AP
1985-05-28Manufacturing (CMC) · Supplement 23 · standardAP
1984-05-04Labeling · Supplement 21AP
1983-11-10Labeling · Supplement 19AP
1983-01-05Manufacturing (CMC) · Supplement 18 · standardAP
1982-07-08Manufacturing (CMC) · Supplement 14 · standardAP
1982-03-22Manufacturing (CMC) · Supplement 16 · standardAP
1982-03-22Labeling · Supplement 17AP
1982-02-12Manufacturing (CMC) · Supplement 15 · standardAP
1981-08-11Manufacturing (CMC) · Supplement 12 · standardAP
1981-06-24Manufacturing (CMC) · Supplement 13 · standardAP
1980-01-14Manufacturing (CMC) · Supplement 11 · standardAP
1979-06-25Manufacturing (CMC) · Supplement 10 · standardAP
1979-04-03Manufacturing (CMC) · Supplement 9 · standardAP
1976-11-01Manufacturing (CMC) · Supplement 4 · standardAP
1976-11-01Manufacturing (CMC) · Supplement 2 · standardAP
1976-11-01Labeling · Supplement 5AP
1976-11-01Manufacturing (CMC) · Supplement 6 · standardAP
1975-12-08Labeling · Supplement 1AP
1975-05-23Type 3 - New Dosage Form · Original · standardAP
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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