Darvon

NDA 10997, held by Xanodyne Pharm. Propoxyphene Hydrochloride.

As of Nov 13, 2026, NDA 10997 (Darvon), held by Xanodyne Pharm, was first approved by FDA on Aug 16, 1957, with 30 approved supplements and 0 published complete response letters.

First approved: Aug 16, 1957
Review: Priority
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below

Date	Submission	Status	Documents
Aug 16, 1957	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Darvon32MG · capsule;oral	Propoxyphene Hydrochloride	Discontinued
Darvon65MG · capsule;oral	Propoxyphene Hydrochloride	Discontinued

All 31 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 25, 2009	Supplement 52Labeling · Priority review	Approved	Letter Label
Sep 25, 2009	Supplement 51Labeling · Priority review	Approved	Letter Label
Aug 1, 2002	Supplement 43Labeling · Priority review	Approved	Letter
Feb 24, 1999	Supplement 47Manufacturing · Priority review	Approved	None posted
Oct 5, 1998	Supplement 46Manufacturing · Priority review	Approved	None posted
Aug 10, 1998	Supplement 45Manufacturing · Priority review	Approved	None posted
Apr 2, 1998	Supplement 44Manufacturing · Priority review	Approved	None posted
Sep 2, 1994	Supplement 42Labeling · Priority review	Approved	None posted
Aug 23, 1994	Supplement 40Labeling · Priority review	Approved	None posted
Sep 15, 1992	Supplement 41Manufacturing · Priority review	Approved	None posted
Dec 8, 1986	Supplement 35Manufacturing · Priority review	Approved	None posted
Nov 5, 1986	Supplement 32Manufacturing · Priority review	Approved	None posted
Oct 16, 1986	Supplement 33Labeling · Priority review	Approved	None posted
Apr 21, 1986	Supplement 31Labeling · Priority review	Approved	None posted
Apr 21, 1986	Supplement 28Labeling · Priority review	Approved	None posted
Apr 21, 1986	Supplement 27Labeling · Priority review	Approved	None posted
Jan 28, 1985	Supplement 26Manufacturing · Priority review	Approved	None posted
Oct 28, 1981	Supplement 25Labeling · Priority review	Approved	None posted
Aug 10, 1981	Supplement 23Manufacturing · Priority review	Approved	None posted
May 20, 1981	Supplement 24Labeling · Priority review	Approved	None posted
Apr 15, 1980	Supplement 22Labeling · Priority review	Approved	None posted
Jan 21, 1980	Supplement 16Manufacturing · Priority review	Approved	None posted
Sep 26, 1979	Supplement 21Labeling · Priority review	Approved	None posted
Feb 27, 1979	Supplement 18Manufacturing · Priority review	Approved	None posted
Oct 13, 1978	Supplement 20Manufacturing · Priority review	Approved	None posted
May 26, 1978	Supplement 19Manufacturing · Priority review	Approved	None posted
May 3, 1977	Supplement 15Manufacturing · Priority review	Approved	None posted
May 3, 1977	Supplement 14Manufacturing · Priority review	Approved	None posted
Jul 23, 1976	Supplement 13Labeling · Priority review	Approved	None posted
Jan 6, 1975	Supplement 10Labeling · Priority review	Approved	None posted
Aug 16, 1957	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 10997
Drugs@FDA: Overview at FDA
Company: Xanodyne Pharmaceuticals

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