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Serving leading biopharmaceutical companies globally:

Cerilliant
Express Scripts
Healthtrust
Moodys
Merck
Colorcon
UBS
Covington
Mallinckrodt
Medtronic

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020763

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NDA 020763 describes AMERGE, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. Additional details are available on the AMERGE profile page.

The generic ingredient in AMERGE is naratriptan hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.
Summary for 020763
Tradename:AMERGE
Applicant:Glaxosmithkline Llc
Ingredient:naratriptan hydrochloride
Patents:0
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020763
Suppliers and Packaging for NDA: 020763
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMERGE naratriptan hydrochloride TABLET;ORAL 020763 NDA GlaxoSmithKline LLC 0173-0561 0173-0561-00 9 TABLET, FILM COATED in 1 BLISTER PACK (0173-0561-00)
AMERGE naratriptan hydrochloride TABLET;ORAL 020763 NDA GlaxoSmithKline LLC 0173-0562 0173-0562-00 9 TABLET, FILM COATED in 1 BLISTER PACK (0173-0562-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Feb 10, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Feb 10, 1998TE:ABRLD:Yes

Expired US Patents for NDA 020763

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc AMERGE naratriptan hydrochloride TABLET;ORAL 020763-002 Feb 10, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc AMERGE naratriptan hydrochloride TABLET;ORAL 020763-001 Feb 10, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Medtronic
US Department of Justice
Harvard Business School
Mallinckrodt
Johnson and Johnson
Chubb
AstraZeneca

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