APPLICATION
NDA006035
TYPE
NDA
ORIGINAL APPROVAL
1946-11-19
LATEST ACTION
2025-05-29
ROUTE
INJECTION, ORAL
DOSAGE FORM
INJECTABLE, TABLET
MARKETING STATUS
Discontinued
Products
METHERGINE · ReferenceDiscontinued
METHYLERGONOVINE MALEATE 0.2MG/ML · INJECTABLE · INJECTION
METHERGINE · ReferenceDiscontinued
METHYLERGONOVINE MALEATE 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2013-05-21Manufacturing (CMC) · Supplement 79AP
2002-02-05Manufacturing (CMC) · Supplement 68AP
2002-02-05Manufacturing (CMC) · Supplement 69AP
2002-01-28Manufacturing (CMC) · Supplement 67AP
2001-05-22Manufacturing (CMC) · Supplement 65AP
2001-04-03Manufacturing (CMC) · Supplement 66AP
2000-04-14Manufacturing (CMC) · Supplement 64AP
1999-12-09Manufacturing (CMC) · Supplement 63AP
1999-04-22Manufacturing (CMC) · Supplement 62AP
1997-07-15Manufacturing (CMC) · Supplement 61AP
1997-05-27Labeling · Supplement 60 · standardAP
1996-02-22Labeling · Supplement 58 · standardAP
1996-02-21Manufacturing (CMC) · Supplement 59AP
1995-10-17Manufacturing (CMC) · Supplement 57AP
1995-09-22Manufacturing (CMC) · Supplement 56AP
1995-09-22Manufacturing (CMC) · Supplement 55AP
1995-03-22Labeling · Supplement 50AP
1994-07-18Manufacturing (CMC) · Supplement 51AP
1994-07-07Manufacturing (CMC) · Supplement 54AP
1994-04-25Labeling · Supplement 52 · standardAP
1993-03-11Manufacturing (CMC) · Supplement 53AP
1991-05-28Labeling · Supplement 49AP
1990-09-06Manufacturing (CMC) · Supplement 48AP
1989-10-20Manufacturing (CMC) · Supplement 46AP
1989-10-20Manufacturing (CMC) · Supplement 44AP
1989-10-20Manufacturing (CMC) · Supplement 47AP
1989-10-20Manufacturing (CMC) · Supplement 43AP
1989-03-02Manufacturing (CMC) · Supplement 42AP
1987-07-06Manufacturing (CMC) · Supplement 36AP
1987-05-06Labeling · Supplement 37AP
1986-01-07Labeling · Supplement 34AP
1985-09-30Labeling · Supplement 31AP
1985-06-18Manufacturing (CMC) · Supplement 32AP
1985-05-14Manufacturing (CMC) · Supplement 33AP
1984-10-22Manufacturing (CMC) · Supplement 29AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.