Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020626


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NDA 020626 describes IMITREX, which is a drug marketed by Glaxosmithkline and is included in three NDAs. It is available from two suppliers. Additional details are available on the IMITREX profile page.

The generic ingredient in IMITREX is sumatriptan. There are two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.
Summary for 020626
Tradename:IMITREX
Applicant:Glaxosmithkline
Ingredient:sumatriptan
Patents:0
Medical Subject Heading (MeSH) Categories for 020626
Serotonin 5-HT1 Receptor Agonists
Vasoconstrictor Agents
Suppliers and Packaging for NDA: 020626
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMITREX sumatriptan SPRAY;NASAL 020626 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-081 66993-081-69 6 CONTAINER in 1 BOX (66993-081-69) / 100 uL in 1 CONTAINER
IMITREX sumatriptan SPRAY;NASAL 020626 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-082 66993-082-69 6 CONTAINER in 1 BOX (66993-082-69) / 100 uL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength5MG/SPRAY
Approval Date:Aug 26, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY;NASALStrength10MG/SPRAY
Approval Date:Aug 26, 1997TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength20MG/SPRAY
Approval Date:Aug 26, 1997TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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