APPLICATION
NDA017993
TYPE
NDA
ORIGINAL APPROVAL
1977-12-30
LATEST ACTION
2001-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDERGINEDiscontinued
ERGOLOID MESYLATES 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
HYDERGINE · ReferenceDiscontinued
ERGOLOID MESYLATES 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-04-02Manufacturing (CMC) · Supplement 35 · standardAP
2000-08-01Manufacturing (CMC) · Supplement 34 · standardAP
2000-05-10Manufacturing (CMC) · Supplement 33 · standardAP
2000-03-13Manufacturing (CMC) · Supplement 32 · standardAP
1998-11-12Labeling · Supplement 27 · standardAP
1996-06-18Manufacturing (CMC) · Supplement 31 · standardAP
1995-12-07Manufacturing (CMC) · Supplement 29 · standardAP
1995-10-12Manufacturing (CMC) · Supplement 28 · standardAP
1994-02-28Manufacturing (CMC) · Supplement 23 · standardAP
1994-02-28Manufacturing (CMC) · Supplement 21 · standardAP
1993-09-14Manufacturing (CMC) · Supplement 26 · standardAP
1989-11-07Manufacturing (CMC) · Supplement 20 · standardAP
1987-05-26Manufacturing (CMC) · Supplement 19 · standardAP
1985-02-07Manufacturing (CMC) · Supplement 17 · standardAP
1983-10-26Labeling · Supplement 16 · standardAP
1983-02-03Labeling · Supplement 14 · standardAP
1983-01-19Manufacturing (CMC) · Supplement 11 · standardAP
1982-09-15Manufacturing (CMC) · Supplement 12 · standardAP
1982-03-25Manufacturing (CMC) · Supplement 10 · standardAP
1981-09-02Manufacturing (CMC) · Supplement 8 · standardAP
1981-08-10Manufacturing (CMC) · Supplement 9 · standardAP
1981-02-04Labeling · Supplement 4 · standardAP
1981-02-03Manufacturing (CMC) · Supplement 7 · standardAP
1979-12-11Manufacturing (CMC) · Supplement 5 · standardAP
1979-08-01Manufacturing (CMC) · Supplement 2 · standardAP
1979-04-05Manufacturing (CMC) · Supplement 3 · standardAP
1978-06-30Manufacturing (CMC) · Supplement 1 · standardAP
1977-12-30Type 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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