Details for New Drug Application (NDA): 022519
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NDA 022519 describes DUEXIS, which is a drug marketed by Horizon and is included in one NDA. It is available from two suppliers. There are five 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. Eleven suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.
The generic ingredient in DUEXIS is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.
Summary for 022519
| Tradename: | DUEXIS |
| Applicant: | Horizon |
| Ingredient: | famotidine; ibuprofen |
| Patents: | 5 |
Pharmacology for NDA: 022519
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists |
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 AUTHORIZED GENERIC | Lupin Pharmaceuticals, Inc. | 70748-312 | 70748-312-09 | 90 TABLET, COATED in 1 BOTTLE (70748-312-09) |
| DUEXIS | famotidine; ibuprofen | TABLET;ORAL | 022519 | NDA | Horizon Therapeutics USA, Inc. | 75987-010 | 75987-010-03 | 90 TABLET, COATED in 1 BOTTLE (75987-010-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 23, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 18, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 18, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 18, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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