TOSYMRA
These highlights do not include all the information needed to use TOSYMRA safely and effectively. See full prescribing information for TOSYMRA. TOSYMRA (sumatriptan) nasal spray Initial U.S. Approval: 1992
Approved
Approval ID
015a5cf9-f246-48bc-b91e-cd730a53d8aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 079111820
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sumatriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0245-0812
Application NumberNDA210884
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan
Product Specifications
Route of AdministrationNASAL
Effective DateFebruary 28, 2021
FDA Product Classification
INGREDIENTS (7)
SumatriptanActive
Quantity: 10 mg in 0.1 mL
Code: 8R78F6L9VO
Classification: ACTIB
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MONOBASIC POTASSIUM PHOSPHATEInactive
Code: 4J9FJ0HL51
Classification: IACT
N-DODECYL .BETA.-D-MALTOSIDEInactive
Code: DI107E57B4
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT