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FDA Approval

Migranal

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

FDA Approval Summary

Company
Bausch Health US, LLC
DUNS: 831922468
Effective Date
September 1, 2022
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 SpA

Bausch Health US, LLC

514042399

Products1

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

Migranal

Product Details

NDC Product Code
0187-0245
Application Number
NDA020148
Marketing Category
NDA (C73594)
Route of Administration
NASAL
Effective Date
September 1, 2022
Code: 81AXN7R2QTClass: ACTIBQuantity: 4 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Carbon DioxideInactive
Code: 142M471B3JClass: IACT
Anhydrous DextroseInactive
Code: 5SL0G7R0OKClass: IACT
CaffeineInactive
Code: 3G6A5W338EClass: IACT
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