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Sumatriptan

These highlights do not include all the information needed to use SUMATRIPTAN NASAL SPRAY safely and effectively. See full prescribing information for SUMATRIPTAN NASAL SPRAY. SUMATRIPTAN nasal sprayInitial U.S. Approval: 1992

Approved
Approval ID

559cca31-c0d2-45bf-999d-e92fc49a4a89

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 29, 2021

Manufacturers
FDA

Cipla USA Inc.

DUNS: 078719707

Products 1

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

Sumatriptan

PRODUCT DETAILS

NDC Product Code69097-644
Application NumberANDA214209
Marketing CategoryC73584
Route of AdministrationNASAL
Effective DateJanuary 29, 2021
Generic NameSumatriptan

INGREDIENTS (6)

POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
SUMATRIPTANActive
Quantity: 20 mg in 1 1
Code: 8R78F6L9VO
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT

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Sumatriptan - FDA Drug Approval Details