SUMATRIPTAN
SumatriptanNasal Spray
Approved
Approval ID
24bc527e-c682-4c66-964e-c21d31eca5dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6052
Application NumberNDA020626
Product Classification
M
Marketing Category
C73594
G
Generic Name
sumatriptan
Product Specifications
Route of AdministrationNASAL
Effective DateDecember 12, 2011
FDA Product Classification
INGREDIENTS (6)
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
SUMATRIPTANActive
Quantity: 20 mg in 100 uL
Code: 8R78F6L9VO
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT