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Cabotegravir; Rilpivirine

Sold as Cabenuva. Every branded application for this active ingredient.

  • First approved: Jan 21, 2021
  • Branded applications: 1
  • New uses approved: 6
  • Complete response letters: 1

Applications

NDAs and BLAs for this ingredient, oldest first; each opens its full history
ApprovedApplicationSponsorSupplementsMarketing
Jan 21, 2021CabenuvaNDA 212888 · New molecular entity, new combinationViiv Hlthcare10Marketed

Complete Response Letters

FDA's published letters for these applications
LetterProductNow
Dec 19, 2019NDA 212888Product Quality/Facility Inspections, Product QualityApproved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Drugs@FDA

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.