Dihydroergotamine Mesylate Nasal
Dihydroertotamine Mesylate Nasal Spray, 4 mg/mL
Approved
Approval ID
ed1b7598-1778-4c0e-abe0-1ee96c728aac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2020
Manufacturers
FDA
Exelan Pharmaceuticals, Inc.
DUNS: 967795266
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dihydroergotamine Mesylate Nasal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-680
Application NumberANDA212907
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dihydroergotamine Mesylate Nasal
Product Specifications
Route of AdministrationNASAL
Effective DateDecember 10, 2020
FDA Product Classification
INGREDIENTS (5)
DIHYDROERGOTAMINE MESYLATEActive
Quantity: 4 mg in 1 mL
Code: 81AXN7R2QT
Classification: ACTIB
CAFFEINEInactive
Code: 3G6A5W338E
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
CARBON DIOXIDEInactive
Code: 142M471B3J
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT