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FDA Approval

Dihydroergotamine Mesylate Nasal

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

FDA Approval Summary

Company
Effective Date
December 10, 2020
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., Italy

Exelan Pharmaceuticals, Inc.

514042399

Products1

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

Dihydroergotamine Mesylate Nasal

Product Details

NDC Product Code
76282-680
Application Number
ANDA212907
Marketing Category
ANDA (C73584)
Route of Administration
NASAL
Effective Date
December 10, 2020
Code: 81AXN7R2QTClass: ACTIBQuantity: 4 mg in 1 mL
CAFFEINEInactive
Code: 3G6A5W338EClass: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OKClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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