APPLICATION
NDA009000
TYPE
NDA
ORIGINAL APPROVAL
1953-04-24
LATEST ACTION
2002-06-04
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
CAFERGOT · ReferenceDiscontinued
CAFFEINE 100MG, ERGOTAMINE TARTRATE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUPPOSITORY · RECTAL
Approval history
2001-11-07Manufacturing (CMC) · Supplement 28 · priorityAP
2001-04-02Manufacturing (CMC) · Supplement 27 · priorityAP
2001-03-29Manufacturing (CMC) · Supplement 26 · priorityAP
2000-10-31Labeling · Supplement 17 · priorityAP
2000-10-31Labeling · Supplement 15 · priorityAP
2000-10-31Labeling · Supplement 21 · priorityAP
2000-10-31Labeling · Supplement 13 · priorityAP
2000-10-31Labeling · Supplement 20 · priorityAP
2000-05-16Manufacturing (CMC) · Supplement 24 · priorityAP
1994-03-04Manufacturing (CMC) · Supplement 14 · priorityAP
1993-07-14Manufacturing (CMC) · Supplement 19 · priorityAP
1993-04-15Manufacturing (CMC) · Supplement 16 · priorityAP
1989-02-10Manufacturing (CMC) · Supplement 11 · priorityAP
1988-11-17Manufacturing (CMC) · Supplement 12 · priorityAP
1988-11-15Manufacturing (CMC) · Supplement 10 · priorityAP
1986-07-25Manufacturing (CMC) · Supplement 9 · priorityAP
1985-01-16Manufacturing (CMC) · Supplement 7 · priorityAP
1981-07-15Manufacturing (CMC) · Supplement 6 · priorityAP
1981-01-29Manufacturing (CMC) · Supplement 5 · priorityAP
1979-11-06Manufacturing (CMC) · Supplement 4 · priorityAP
1979-07-19Manufacturing (CMC) · Supplement 3 · priorityAP
1953-04-24Type 4 - New Combination · 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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