Tetrabenazine

ANDA 206686, held by Actavis Labs Fl Inc. Tetrabenazine.

As of Nov 15, 2026, ANDA 206686 (Tetrabenazine), held by Actavis Labs Fl Inc, was first approved by FDA on Jul 7, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 7, 2017
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

Date	Submission	Status	Documents
Jul 7, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tetrabenazine25MG · tablet;oral	Tetrabenazine	Rx

All 2 submissions, including labeling and manufacturing supplements


Mar 16, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Jul 7, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 206686
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

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