APPLICATION
ANDA086189
TYPE
ANDA
ORIGINAL APPROVAL
1980-07-07
LATEST ACTION
1997-01-31
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GERIMALDiscontinued
ERGOLOID MESYLATES 0.5MG · TABLET · SUBLINGUAL
Approval history
1997-01-31Manufacturing (CMC) · Supplement 24AP
1988-11-25Labeling · Supplement 23AP
1988-09-01Labeling · Supplement 22AP
1988-07-18Manufacturing (CMC) · Supplement 21AP
1986-04-30Manufacturing (CMC) · Supplement 16AP
1986-04-30Manufacturing (CMC) · Supplement 14AP
1986-04-30Manufacturing (CMC) · Supplement 17AP
1985-12-05Manufacturing (CMC) · Supplement 11AP
1985-12-05Manufacturing (CMC) · Supplement 12AP
1985-12-05Manufacturing (CMC) · Supplement 13AP
1985-07-30Manufacturing (CMC) · Supplement 4AP
1980-07-07OriginalAP
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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