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Awiqli Flextouch

BLA 761326, held by Novo Nordisk Inc. Insulin Icodec.

  • First approved: Mar 26, 2026
  • Review: Standard
  • Supplements approved: 1
  • Complete response letters: 1

Approvals and New Uses

The original application and every efficacy supplement, newest first
DateSubmissionStatusDocuments
Oct 23, 2026Supplement 1Efficacy (new indication or use) · Priority reviewApprovedLetterLabel
Mar 26, 2026Original applicationNew molecular entity · Standard reviewApprovedReviewLabelLetter

Complete Response Letters

FDA's published letters for this application; each opens the letter
LetterProductNow
Jul 10, 2024NNC0148-0287Facility Inspections, Chemistry, Manufacturing, And Controls (Cmc), ClinicalUnapproved

Products

1 strengths and forms
ProductActive ingredientMarketing
Awiqli Flextouchinjection;solutionInsulin IcodecRx

Identifiers

Application
BLA 761326

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

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.