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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
Effective Date
March 17, 2023
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
0143-9151
Application Number
ANDA040453
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective Date
March 17, 2023
Code: 81AXN7R2QTClass: ACTIBQuantity: 1 mg in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
METHANESULFONIC ACIDInactive
Code: 12EH9M7279Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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