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Generated: May 21, 2019

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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 four suppliers. Additional details are available on the IMITREX profile page.

The generic ingredient in IMITREX is sumatriptan. There are twenty-four drug master file entries for this compound. Three 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020626
Medical Subject Heading (MeSH) Categories for 020626
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 GlaxoSmithKline LLC 0173-0523 0173-0523-00 6 CONTAINER in 1 BOX (0173-0523-00) > 1 SPRAY in 1 CONTAINER
IMITREX sumatriptan SPRAY;NASAL 020626 NDA GlaxoSmithKline LLC 0173-0524 0173-0524-00 6 CONTAINER in 1 BOX (0173-0524-00) > 1 SPRAY 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

Expired US Patents for NDA 020626

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-002 Aug 26, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Baxter
McKesson
QuintilesIMS
Teva

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