Septocaine

NDA 20971, held by Deproco. Articaine Hydrochloride; Epinephrine Bitartrate.

As of Nov 13, 2026, NDA 20971 (Septocaine), held by Deproco, was first approved by FDA on Apr 3, 2000, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 3, 2000
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Apr 3, 2000	Original applicationNew molecular entity, new combination · Standard review	Approved	Review Letter Label

Products

2 strengths and forms

Product	Active ingredient	Marketing
Septocaine4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML) · injectable;injection	Articaine Hydrochloride; Epinephrine Bitartrate	RxReference drug
Septocaine4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML) · injectable;injection	Articaine Hydrochloride; Epinephrine Bitartrate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 2, 2018	Supplement 42Labeling · Standard review	Approved	Letter Label
Jan 12, 2017	Supplement 36Manufacturing · Standard review	Approved	None posted
Oct 27, 2016	Supplement 35Manufacturing	Approved	None posted
Jan 26, 2015	Supplement 34Manufacturing · Standard review	Approved	None posted
Jun 5, 2014	Supplement 32Manufacturing · Standard review	Approved	None posted
Jun 5, 2014	Supplement 33Manufacturing · Standard review	Approved	None posted
Feb 14, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Jan 31, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 8, 2013	Supplement 28Manufacturing · Standard review	Approved	None posted
Nov 12, 2010	Supplement 23Labeling · Standard review	Approved	Review Letter
Feb 22, 2010	Supplement 21Labeling · Standard review	Approved	Review Label Letter
Nov 9, 2006	Supplement 17Labeling · Standard review	Approved	Letter Label
Mar 30, 2006	Supplement 13Labeling · Standard review	Approved	Review
Mar 30, 2006	Supplement 15Labeling · Standard review	Approved	None posted
Feb 4, 2005	Supplement 9Labeling · Standard review	Approved	Review Letter
Oct 14, 2004	Supplement 7Labeling · Standard review	Approved	Letter
Jul 23, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 3, 2000	Original applicationNew molecular entity, new combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20971
Drugs@FDA: Overview at FDA
Company: Deproco

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