APPLICATION
NDA015874
TYPE
NDA
ORIGINAL APPROVAL
1974-05-13
LATEST ACTION
2002-11-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALUPENTDiscontinued
METAPROTERENOL SULFATE 20MG · TABLET · ORAL
ALUPENTDiscontinued
METAPROTERENOL SULFATE 10MG · TABLET · ORAL
Approval history
2002-11-12Labeling · Supplement 24AP
2002-11-12Labeling · Supplement 37 · standardAP
1992-04-28Labeling · Supplement 35AP
1991-03-11Labeling · Supplement 36AP
1986-02-14Labeling · Supplement 34AP
1985-12-10Manufacturing (CMC) · Supplement 32 · priorityAP
1985-12-10Manufacturing (CMC) · Supplement 30 · priorityAP
1984-05-04Labeling · Supplement 33AP
1983-11-10Labeling · Supplement 31AP
1983-05-05Manufacturing (CMC) · Supplement 27 · priorityAP
1983-05-05Labeling · Supplement 28AP
1983-01-05Manufacturing (CMC) · Supplement 29 · priorityAP
1982-02-12Manufacturing (CMC) · Supplement 26 · priorityAP
1981-06-24Manufacturing (CMC) · Supplement 25 · priorityAP
1981-04-07Manufacturing (CMC) · Supplement 23 · priorityAP
1980-09-11Manufacturing (CMC) · Supplement 22 · priorityAP
1980-05-05Manufacturing (CMC) · Supplement 17 · priorityAP
1980-01-09Manufacturing (CMC) · Supplement 21 · priorityAP
1979-06-26Manufacturing (CMC) · Supplement 20 · priorityAP
1978-06-28Labeling · Supplement 19AP
1977-08-08Labeling · Supplement 18AP
1977-08-08Manufacturing (CMC) · Supplement 12 · priorityAP
1976-12-08Manufacturing (CMC) · Supplement 15 · priorityAP
1976-11-12Manufacturing (CMC) · Supplement 14 · priorityAP
1976-11-12Manufacturing (CMC) · Supplement 13 · priorityAP
1976-10-29Manufacturing (CMC) · Supplement 16 · priorityAP
1976-09-23Labeling · Supplement 6AP
1976-07-20Manufacturing (CMC) · Supplement 10 · priorityAP
1976-07-20Manufacturing (CMC) · Supplement 11 · priorityAP
1976-07-19Manufacturing (CMC) · Supplement 8 · priorityAP
1976-04-26Manufacturing (CMC) · Supplement 9 · priorityAP
1976-03-11Manufacturing (CMC) · Supplement 7 · priorityAP
1974-12-19Manufacturing (CMC) · Supplement 4 · priorityAP
1974-12-19Manufacturing (CMC) · Supplement 5 · priorityAP
1974-12-19Manufacturing (CMC) · Supplement 3 · priorityAP
1974-12-19Manufacturing (CMC) · Supplement 1 · priorityAP
1974-05-13Type 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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