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Details for New Drug Application (NDA): 021926

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NDA 021926 describes TREXIMET, which is a drug marketed by Pernix Ireland Ltd and is included in one NDA. It is available from three suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TREXIMET profile page.

The generic ingredient in TREXIMET is naproxen sodium; sumatriptan succinate. There are forty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.

Summary for NDA: 021926

Pernix Ireland Ltd
naproxen sodium; sumatriptan succinate
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021926

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naproxen sodium; sumatriptan succinate
TABLET;ORAL 021926 NDA GlaxoSmithKline LLC 0173-0750 0173-0750-49 9 TABLET, FILM COATED in 1 BOTTLE (0173-0750-49)
naproxen sodium; sumatriptan succinate
TABLET;ORAL 021926 NDA Rebel Distributors Corp 21695-954 21695-954-09 9 TABLET, FILM COATED in 1 CONTAINER (21695-954-09)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 85MG BASE
Approval Date:Apr 15, 2008TE:RLD:Yes
Patent:6,060,499*PEDPatent Expiration:Feb 14, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,586,458*PEDPatent Expiration:Feb 14, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:7,332,183*PEDPatent Expiration:Apr 2, 2026Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021926

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Ireland Ltd
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-001Apr 15, 20085,037,845► subscribe
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