Talacen

NDA 18458, held by Sanofi Aventis US. Acetaminophen; Pentazocine Hydrochloride.

As of Nov 13, 2026, NDA 18458 (Talacen), held by Sanofi Aventis US, was first approved by FDA on Sep 23, 1982, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 23, 1982
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Sep 23, 1982	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Talacen650MG;EQ 25MG BASE · tablet;oral	Acetaminophen; Pentazocine Hydrochloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 22, 2011	Supplement 16Labeling · Standard review	Approved	Label Letter
Mar 10, 2011	Supplement 14Labeling · Standard review	Approved	Letter Label
Aug 7, 2008	Supplement 13Labeling · Standard review	Approved	Letter
Jul 10, 2003	Supplement 12Labeling · Standard review	Approved	Letter
Oct 31, 2000	Supplement 10Labeling · Standard review	Approved	None posted
Mar 30, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 10, 1988	Supplement 7Labeling · Standard review	Approved	None posted
Mar 2, 1988	Supplement 8Manufacturing · Standard review	Approved	None posted
May 22, 1987	Supplement 6Labeling · Standard review	Approved	None posted
Mar 27, 1987	Supplement 5Labeling · Standard review	Approved	None posted
Oct 25, 1985	Supplement 4Labeling · Standard review	Approved	None posted
May 7, 1985	Supplement 3Labeling · Standard review	Approved	None posted
Jun 26, 1984	Supplement 2Labeling · Standard review	Approved	None posted
Jan 24, 1984	Supplement 1Labeling · Standard review	Approved	None posted
Sep 23, 1982	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18458
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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