APPLICATION
NDA009087
TYPE
NDA
ORIGINAL APPROVAL
1953-11-05
LATEST ACTION
2000-05-10
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDERGINEDiscontinued
ERGOLOID MESYLATES 0.5MG · TABLET · SUBLINGUAL
HYDERGINEDiscontinued
ERGOLOID MESYLATES 1MG · TABLET · SUBLINGUAL
Approval history
2000-05-10Manufacturing (CMC) · Supplement 47 · standardAP
1999-04-21Manufacturing (CMC) · Supplement 46 · standardAP
1998-11-12Labeling · Supplement 45 · standardAP
1993-09-14Manufacturing (CMC) · Supplement 44 · standardAP
1993-04-06Manufacturing (CMC) · Supplement 41 · standardAP
1989-11-07Manufacturing (CMC) · Supplement 39 · standardAP
1987-05-26Manufacturing (CMC) · Supplement 38 · standardAP
1983-10-26Labeling · Supplement 36 · standardAP
1983-08-26Manufacturing (CMC) · Supplement 35 · standardAP
1983-02-03Labeling · Supplement 33 · standardAP
1983-01-19Manufacturing (CMC) · Supplement 31 · standardAP
1981-09-02Manufacturing (CMC) · Supplement 29 · standardAP
1981-08-10Manufacturing (CMC) · Supplement 30 · standardAP
1981-02-24Manufacturing (CMC) · Supplement 27 · standardAP
1981-02-04Labeling · Supplement 24 · standardAP
1981-01-19Manufacturing (CMC) · Supplement 28 · standardAP
1979-12-11Manufacturing (CMC) · Supplement 26 · standardAP
1979-06-14Manufacturing (CMC) · Supplement 25 · standardAP
1978-10-16Manufacturing (CMC) · Supplement 21 · standardAP
1978-07-13Manufacturing (CMC) · Supplement 22 · standardAP
1978-06-27Manufacturing (CMC) · Supplement 20 · standardAP
1978-04-14Labeling · Supplement 19 · standardAP
1978-03-20Manufacturing (CMC) · Supplement 17 · standardAP
1976-07-28Manufacturing (CMC) · Supplement 13 · standardAP
1976-06-30Manufacturing (CMC) · Supplement 12 · standardAP
1976-02-23Manufacturing (CMC) · Supplement 11 · standardAP
1975-11-13Manufacturing (CMC) · Supplement 9 · standardAP
1975-10-06Manufacturing (CMC) · Supplement 8 · standardAP
1975-06-25Manufacturing (CMC) · Supplement 7 · standardAP
1975-06-02Efficacy · Supplement 6 · standardAP
1975-04-16REMS · Supplement 4 · standardAP
1974-12-13Manufacturing (CMC) · Supplement 5 · standardAP
1974-06-25Manufacturing (CMC) · Supplement 2 · standardAP
1953-11-05Type 1 - New Molecular Entity · 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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