← FDA DRUG APPROVALS

FDA ANDA · ANDA040889

METHYLERGONOVINE MALEATE

Sponsor: BRECKENRIDGE

APPLICATION
ANDA040889
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-13
LATEST ACTION
2013-01-31
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

METHYLERGONOVINE MALEATEPrescription
METHYLERGONOVINE MALEATE 0.2MG/ML · INJECTABLE · INJECTION

Approval history

2013-01-31Labeling · Supplement 1 · standardAP
2010-09-13OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →