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FDA Approval

dihydroergotamine mesylate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Sagent Pharmaceuticals
DUNS: 796852890
Effective Date
May 2, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dihydroergotamine(1 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

dihydroergotamine mesylate

Product Details

NDC Product Code
25021-609
Application Number
ANDA207264
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective Date
May 2, 2022
alcoholInactive
Code: 3K9958V90MClass: IACT
Code: 81AXN7R2QTClass: ACTIBQuantity: 1 mg in 1 mL
glycerinInactive
Code: PDC6A3C0OXClass: IACT
methanesulfonic acidInactive
Code: 12EH9M7279Class: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
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