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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
Advagen Pharma Ltd
DUNS: 051627256
Effective Date
July 5, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dihydroergotamine(4 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Mipharm, S.p.A.

Advagen Pharma Ltd

514042399

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
72888-096
Application Number
ANDA216881
Marketing Category
ANDA (C73584)
Route of Administration
NASAL
Effective Date
July 5, 2023
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OKClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
Code: 81AXN7R2QTClass: ACTIBQuantity: 4 mg in 1 mL
CAFFEINEInactive
Code: 3G6A5W338EClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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