APPLICATION
ANDA084294
TYPE
ANDA
ORIGINAL APPROVAL
1976-09-29
LATEST ACTION
2008-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CAFERGOT · ReferenceDiscontinued
CAFFEINE 100MG, ERGOTAMINE TARTRATE 1MG · TABLET · ORAL
Approval history
2008-04-14Labeling · Supplement 83AP
2003-10-03Labeling · Supplement 75AP
1999-07-26Manufacturing (CMC) · Supplement 72AP
1994-01-24Manufacturing (CMC) · Supplement 71AP
1987-02-03Manufacturing (CMC) · Supplement 70AP
1987-02-03Manufacturing (CMC) · Supplement 69AP
1986-02-05Manufacturing (CMC) · Supplement 68AP
1984-12-17Manufacturing (CMC) · Supplement 67AP
1984-10-03Manufacturing (CMC) · Supplement 64AP
1984-10-03Manufacturing (CMC) · Supplement 65AP
1984-07-26Manufacturing (CMC) · Supplement 66AP
1983-09-09Manufacturing (CMC) · Supplement 63AP
1983-07-18Manufacturing (CMC) · Supplement 61AP
1983-06-06Manufacturing (CMC) · Supplement 60AP
1983-03-24Manufacturing (CMC) · Supplement 58AP
1982-07-01Manufacturing (CMC) · Supplement 51AP
1982-07-01Manufacturing (CMC) · Supplement 52AP
1982-07-01Manufacturing (CMC) · Supplement 53AP
1976-09-29OriginalAP
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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