Talwin Compound

NDA 16891, held by Sanofi Aventis US. Aspirin; Pentazocine Hydrochloride.

As of Nov 13, 2026, NDA 16891 (Talwin Compound), held by Sanofi Aventis US, was first approved by FDA on Nov 12, 1975, with 18 approved supplements and 0 published complete response letters.

First approved: Nov 12, 1975
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Nov 12, 1975	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Talwin Compound325MG;EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Aspirin; Pentazocine Hydrochloride	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 25, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 29, 1995	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 3, 1991	Supplement 18Labeling · Standard review	Approved	None posted
Jan 5, 1989	Supplement 9Labeling · Standard review	Approved	None posted
Jan 5, 1989	Supplement 15Labeling · Standard review	Approved	None posted
Jan 5, 1989	Supplement 16Labeling · Standard review	Approved	None posted
Mar 17, 1988	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 9, 1982	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 1, 1981	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 2, 1981	Supplement 11Labeling · Standard review	Approved	None posted
Nov 5, 1980	Supplement 10Manufacturing · Standard review	Approved	None posted
May 30, 1979	Supplement 8Manufacturing · Standard review	Approved	None posted
May 8, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
May 8, 1979	Supplement 6Manufacturing · Standard review	Approved	None posted
May 8, 1979	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 9, 1977	Supplement 4Manufacturing · Standard review	Approved	None posted
May 13, 1977	Supplement 2Labeling · Standard review	Approved	None posted
Feb 23, 1976	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 12, 1975	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 16891
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