APPLICATION
NDA005929
TYPE
NDA
ORIGINAL APPROVAL
1946-04-12
LATEST ACTION
2022-05-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
D.H.E. 45 · ReferenceDiscontinued
DIHYDROERGOTAMINE MESYLATE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2001-12-04Manufacturing (CMC) · Supplement 40AP
2001-10-03Manufacturing (CMC) · Supplement 39AP
2001-04-02Manufacturing (CMC) · Supplement 38AP
2000-11-30Manufacturing (CMC) · Supplement 36AP
2000-09-19Manufacturing (CMC) · Supplement 37AP
2000-05-16Manufacturing (CMC) · Supplement 34AP
1999-01-19Manufacturing (CMC) · Supplement 31AP
1998-01-29Labeling · Supplement 19AP
1998-01-29Labeling · Supplement 25 · standardAP
1997-03-07Manufacturing (CMC) · Supplement 29AP
1995-08-10Manufacturing (CMC) · Supplement 28AP
1994-05-23Labeling · Supplement 26 · standardAP
1993-03-09Manufacturing (CMC) · Supplement 18AP
1992-07-07Manufacturing (CMC) · Supplement 16AP
1990-04-04Manufacturing (CMC) · Supplement 15AP
1989-09-22Manufacturing (CMC) · Supplement 14AP
1988-12-02Manufacturing (CMC) · Supplement 8AP
1987-01-08Manufacturing (CMC) · Supplement 6AP
1983-10-24Manufacturing (CMC) · Supplement 7AP
1982-09-15Manufacturing (CMC) · Supplement 5AP
1981-01-27Manufacturing (CMC) · Supplement 4AP
1979-05-31Manufacturing (CMC) · Supplement 3AP
1946-04-12UNKNOWN · Original · unknownAP
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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