Talwin 50

NDA 16732, held by Sanofi Aventis US. Pentazocine Hydrochloride.

As of Nov 13, 2026, NDA 16732 (Talwin 50), held by Sanofi Aventis US, was first approved by FDA on Feb 3, 1969, with 23 approved supplements and 0 published complete response letters.

First approved: Feb 3, 1969
Review: Priority
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Feb 3, 1969	Original applicationNew active ingredient · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Talwin 50EQ 50MG BASE · tablet;oral	Pentazocine Hydrochloride	Discontinued

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 19, 1982	Supplement 51Manufacturing · Priority review	Approved	None posted
Oct 2, 1981	Supplement 47Labeling · Priority review	Approved	None posted
Jan 9, 1981	Supplement 46Manufacturing · Priority review	Approved	None posted
Oct 2, 1980	Supplement 45Manufacturing · Priority review	Approved	None posted
Aug 19, 1980	Supplement 44Manufacturing · Priority review	Approved	None posted
Sep 5, 1979	Supplement 43Labeling · Priority review	Approved	None posted
Jul 23, 1979	Supplement 42Labeling · Priority review	Approved	None posted
May 31, 1979	Supplement 41Labeling · Priority review	Approved	None posted
Apr 30, 1979	Supplement 40Labeling · Priority review	Approved	None posted
Apr 11, 1979	Supplement 39Labeling · Priority review	Approved	None posted
Nov 28, 1978	Supplement 37Manufacturing · Priority review	Approved	None posted
Nov 6, 1978	Supplement 38Manufacturing · Priority review	Approved	None posted
Nov 28, 1977	Supplement 36Manufacturing · Priority review	Approved	None posted
Aug 30, 1977	Supplement 35Labeling · Priority review	Approved	None posted
May 11, 1977	Supplement 34Manufacturing · Priority review	Approved	None posted
Jul 16, 1976	Supplement 33Labeling · Priority review	Approved	None posted
Oct 31, 1975	Supplement 30Labeling · Priority review	Approved	None posted
Jul 30, 1975	Supplement 29Manufacturing · Priority review	Approved	None posted
Jul 30, 1975	Supplement 28Manufacturing · Priority review	Approved	None posted
Apr 3, 1975	Supplement 27Manufacturing · Priority review	Approved	None posted
Dec 9, 1974	Supplement 25Labeling · Priority review	Approved	None posted
Nov 8, 1974	Supplement 22Labeling · Priority review	Approved	None posted
Sep 26, 1974	Supplement 26Labeling · Priority review	Approved	None posted
Feb 3, 1969	Original applicationNew active ingredient · Priority review	Approved	None posted

Identifiers

Application: NDA 16732
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