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Brexpiprazole

ANDA 213512, held by Lupin. Brexpiprazole.

  • First approved: Mar 18, 2023
  • Review: Standard
  • Supplements approved: 1
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below
DateSubmissionStatusDocuments
Mar 18, 2023Original applicationApprovedLetter

Products

6 strengths and forms
ProductActive ingredientMarketing
Brexpiprazole0.25MG · tablet;oralBrexpiprazoleDiscontinued
Brexpiprazole0.5MG · tablet;oralBrexpiprazoleDiscontinued
Brexpiprazole1MG · tablet;oralBrexpiprazoleDiscontinued
Brexpiprazole2MG · tablet;oralBrexpiprazoleDiscontinued
Brexpiprazole3MG · tablet;oralBrexpiprazoleDiscontinued
Brexpiprazole4MG · tablet;oralBrexpiprazoleDiscontinued
All 2 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Nov 12, 2024Supplement 1Labeling · Standard reviewApprovedNone posted
Mar 18, 2023Original applicationApprovedLetter

Identifiers

Application
ANDA 213512
Company
Lupin

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.