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Details for New Drug Application (NDA): 022519

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NDA 022519 describes DUEXIS, which is a drug marketed by Horizon Pharma and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DUEXIS profile page.

The generic ingredient in DUEXIS is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.

Summary for NDA: 022519

Tradename:
DUEXIS
Applicant:
Horizon Pharma
Ingredient:
famotidine; ibuprofen
Patents:6
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022519

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUEXIS
famotidine; ibuprofen
TABLET;ORAL 022519 NDA Horizon Pharma Inc. 75987-010 75987-010-03 90 TABLET, COATED in 1 BOTTLE (75987-010-03)
DUEXIS
famotidine; ibuprofen
TABLET;ORAL 022519 NDA Horizon Pharma Inc. 75987-010 75987-010-72 9 BLISTER PACK in 1 CARTON (75987-010-72) > 3 TABLET, COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength26.6MG;800MG
Approval Date:Apr 23, 2011TE:RLD:Yes
Patent:8,067,033Patent Expiration:Jul 18, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:8,309,127Patent Expiration:Jul 18, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:8,318,202Patent Expiration:Jul 18, 2026Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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