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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
Padagis US LLC
DUNS: 967694121
Effective Date
June 28, 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
0574-0850
Application Number
ANDA040475
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS
Effective Date
August 20, 2018
Code: 81AXN7R2QTClass: ACTIBQuantity: 1 mg in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.061 mL in 1 mL
METHANESULFONIC ACIDInactive
Code: 12EH9M7279Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 0.15 mg in 1 mL
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