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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. Eight suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.

Summary for NDA: 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)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Feb 10, 1998TE:ABRLD:No

Expired Orange Book Patents for NDA: 020763

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
AMERGE
naratriptan hydrochloride
TABLET;ORAL020763-002Feb 10, 19984,997,841► subscribe
Glaxosmithkline Llc
AMERGE
naratriptan hydrochloride
TABLET;ORAL020763-001Feb 10, 19984,997,841► subscribe
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