Arestin

Reduces pocket depth. NDA 50781, held by Orapharma. Minocycline Hydrochloride.

As of Nov 13, 2026, NDA 50781 (Arestin), held by Orapharma, was first approved by FDA on Feb 16, 2001, with 11 approved supplements and 0 published complete response letters.

First approved: Feb 16, 2001
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USE ARESTIN is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN may be used as part of a periodontal maintenance program which includes good oral hygiene and scaling and root planing.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Feb 16, 2001	Original applicationNew dosage form · Standard review	Approved	Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
ArestinEQ 1MG BASE · powder, extended release;dental	Minocycline Hydrochloride	RxReference drug

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 24, 2024	Supplement 25Labeling · Standard review	Approved	Label Letter
May 8, 2017	Supplement 20Labeling · Standard review	Approved	Letter Label
Jul 27, 2012	Supplement 19Labeling · Standard review	Approved	Letter Label
Feb 15, 2008	Supplement 11Manufacturing	Approved	None posted
Feb 15, 2008	Supplement 12Labeling · Standard review	Approved	Label Letter
Jan 28, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 12, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 14, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 14, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 14, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 13, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 16, 2001	Original applicationNew dosage form · Standard review	Approved	Label Review

Identifiers

Application: NDA 50781
Drugs@FDA: Overview at FDA
Company: Orapharma

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