Guanabenz Acetate

ANDA 74267, held by Ani Pharms. Guanabenz Acetate.

As of Nov 15, 2026, ANDA 74267 (Guanabenz Acetate), held by Ani Pharms, was first approved by FDA on Jun 1, 1994, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 1, 1994
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 1, 1994	Original application	Approved	None posted

Products

2 strengths and forms


Guanabenz AcetateEQ 4MG BASE · tablet;oral	Guanabenz Acetate	Discontinued
Guanabenz AcetateEQ 8MG BASE · tablet;oral	Guanabenz Acetate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Mar 23, 1999	Supplement 4Manufacturing	Approved	None posted
Jun 12, 1998	Supplement 3Labeling	Approved	None posted
May 31, 1996	Supplement 2Manufacturing	Approved	None posted
Jun 28, 1994	Supplement 1Labeling	Approved	None posted
Jun 1, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74267
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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