APPLICATION
ANDA212046
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-07
LATEST ACTION
2024-08-28
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DIHYDROERGOTAMINE MESYLATEPrescription
DIHYDROERGOTAMINE MESYLATE 1MG/ML · INJECTABLE · INJECTION
Approval history
2024-08-28Labeling · Supplement 1 · standardAP
2024-08-28Labeling · Supplement 2 · standardAP
2020-01-07UNKNOWN · 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.
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.