APPLICATION
NDA018706
TYPE
NDA
ORIGINAL APPROVAL
1983-01-18
LATEST ACTION
2001-04-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
HYDERGINE LCDiscontinued
ERGOLOID MESYLATES 1MG · CAPSULE · ORAL
Approval history
2001-04-03Manufacturing (CMC) · Supplement 26 · standardAP
2001-03-09Manufacturing (CMC) · Supplement 25 · standardAP
2000-05-10Manufacturing (CMC) · Supplement 24 · standardAP
1999-08-18Manufacturing (CMC) · Supplement 23 · standardAP
1999-04-21Manufacturing (CMC) · Supplement 22 · standardAP
1998-11-12Labeling · Supplement 19 · standardAP
1995-12-07Manufacturing (CMC) · Supplement 21 · standardAP
1994-06-16Manufacturing (CMC) · Supplement 20 · standardAP
1994-02-28Manufacturing (CMC) · Supplement 14 · standardAP
1993-09-02Manufacturing (CMC) · Supplement 17 · standardAP
1993-04-15Manufacturing (CMC) · Supplement 18 · standardAP
1989-11-07Manufacturing (CMC) · Supplement 12 · standardAP
1989-02-09Manufacturing (CMC) · Supplement 11 · standardAP
1987-05-26Manufacturing (CMC) · Supplement 8 · standardAP
1986-06-26Manufacturing (CMC) · Supplement 3 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 6 · standardAP
1983-09-20Labeling · Supplement 5 · standardAP
1983-04-07Manufacturing (CMC) · Supplement 1 · standardAP
1983-01-18Type 3 - New Dosage Form · Original · standardAP
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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