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Generated: November 20, 2018

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Details for New Drug Application (NDA): 020132

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NDA 020132 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 020132
Tradename:IMITREX
Applicant:Glaxosmithkline
Ingredient:sumatriptan succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020132
Suppliers and Packaging for NDA: 020132
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMITREX sumatriptan succinate TABLET;ORAL 020132 NDA GlaxoSmithKline LLC 0173-0735 0173-0735-00 1 CARTON in 1 CARTON (0173-0735-00) > 1 BLISTER PACK in 1 CARTON > 9 TABLET, FILM COATED in 1 BLISTER PACK
IMITREX sumatriptan succinate TABLET;ORAL 020132 NDA GlaxoSmithKline LLC 0173-0736 0173-0736-01 1 CARTON in 1 CARTON (0173-0736-01) > 1 BLISTER PACK in 1 CARTON > 9 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jun 1, 1995TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Jun 1, 1995TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Jun 1, 1995TE:ABRLD:Yes

Expired US Patents for NDA 020132

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-002 Jun 1, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-002 Jun 1, 1995 ➤ Sign Up ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-002 Jun 1, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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