APPLICATION
ANDA087244
TYPE
ANDA
ORIGINAL APPROVAL
1982-08-16
LATEST ACTION
1991-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ERGOLOID MESYLATESDiscontinued
ERGOLOID MESYLATES 1MG · TABLET · ORAL
Approval history
1991-05-31Manufacturing (CMC) · Supplement 13AP
1990-11-19Manufacturing (CMC) · Supplement 14AP
1990-06-29Manufacturing (CMC) · Supplement 12AP
1989-02-07Labeling · Supplement 11AP
1988-12-06Labeling · Supplement 7AP
1988-08-05Manufacturing (CMC) · Supplement 10AP
1988-08-05Manufacturing (CMC) · Supplement 9AP
1988-07-20Bioequivalence · Supplement 8AP
1985-11-27Manufacturing (CMC) · Supplement 3AP
1985-11-27Manufacturing (CMC) · Supplement 4AP
1985-11-27Manufacturing (CMC) · Supplement 2AP
1983-09-02Manufacturing (CMC) · Supplement 1AP
1982-08-16OriginalAP
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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