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Brexpiprazole

ANDA 213562, held by Amneal. Brexpiprazole.

  • First approved: Jan 31, 2023
  • Review: Standard
  • Supplements approved: 5
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below
DateSubmissionStatusDocuments
Jan 31, 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 6 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Apr 1, 2026Supplement 8Labeling · Standard reviewApprovedNone posted
Apr 1, 2026Supplement 7Labeling · Standard reviewApprovedNone posted
Apr 1, 2026Supplement 5Labeling · Standard reviewApprovedNone posted
Apr 1, 2026Supplement 3Labeling · Standard reviewApprovedNone posted
Apr 1, 2026Supplement 2Labeling · Standard reviewApprovedNone posted
Jan 31, 2023Original applicationApprovedLetter

Identifiers

Application
ANDA 213562

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

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