DUEXIS
FAMOTIDINE; IBUPROFEN
Approval overview DUEXIS is listed in Drugs@FDA under application 022519 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient FAMOTIDINE; IBUPROFEN Form and strength TABLET;ORAL - 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HORIZON Submission history Latest submission status date: 2024-11-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview DUEXIS is listed in Drugs@FDA under application 022519 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FAMOTIDINE; IBUPROFEN Form and strength TABLET;ORAL - 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HORIZON Submission history Latest submission status date: 2024-11-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.