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

The generic ingredient in IMITREX is sumatriptan succinate. There are twenty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for NDA: 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 9 TABLET, FILM COATED in 1 BLISTER PACK (0173-0735-00)
IMITREX
sumatriptan succinate
TABLET;ORAL 020132 NDA GlaxoSmithKline LLC 0173-0736 0173-0736-01 9 TABLET, FILM COATED in 1 BLISTER PACK (0173-0736-01)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Jun 1, 1995TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Jun 1, 1995TE:ABRLD:No

Expired Orange Book Patents for NDA: 020132

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-001Jun 1, 19954,816,470*PED► subscribe
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-001Jun 1, 19956,368,627*PED► subscribe
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-002Jun 1, 19954,816,470*PED► subscribe
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