Darvon-N

NDA 16862, held by Xanodyne Pharm. Propoxyphene Napsylate.

As of Nov 13, 2026, NDA 16862 (Darvon-N), held by Xanodyne Pharm, was first approved by FDA on Sep 9, 1971, with 26 approved supplements and 0 published complete response letters.

First approved: Sep 9, 1971
Review: Standard
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Sep 9, 1971	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Darvon-N100MG · tablet;oral	Propoxyphene Napsylate	Discontinued

All 27 submissions, including labeling and manufacturing supplements


Sep 25, 2009	Supplement 42Labeling · Standard review	Approved	Letter Label
Sep 25, 2009	Supplement 41Labeling · Standard review	Approved	Letter Label
Aug 1, 2002	Supplement 33Labeling · Standard review	Approved	Letter
Feb 24, 1999	Supplement 37Manufacturing · Standard review	Approved	None posted
Oct 5, 1998	Supplement 36Manufacturing · Standard review	Approved	None posted
Aug 10, 1998	Supplement 35Manufacturing · Standard review	Approved	None posted
Apr 2, 1998	Supplement 34Manufacturing · Standard review	Approved	None posted
Sep 2, 1994	Supplement 31Labeling · Standard review	Approved	None posted
Aug 23, 1994	Supplement 29Labeling · Standard review	Approved	None posted
Apr 5, 1994	Supplement 32Manufacturing · Standard review	Approved	None posted
Sep 15, 1992	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 15, 1987	Supplement 27Manufacturing · Standard review	Approved	None posted
Oct 16, 1986	Supplement 24Labeling · Standard review	Approved	None posted
Apr 21, 1986	Supplement 18Labeling · Standard review	Approved	None posted
Apr 18, 1986	Supplement 23Manufacturing · Standard review	Approved	None posted
Dec 31, 1985	Supplement 21Labeling · Standard review	Approved	None posted
Apr 16, 1985	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 16, 1984	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 8, 1981	Supplement 15Labeling · Standard review	Approved	None posted
Jan 27, 1981	Supplement 13Labeling · Standard review	Approved	None posted
Jul 24, 1980	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 21, 1980	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 26, 1979	Supplement 12Labeling · Standard review	Approved	None posted
Jan 11, 1978	Supplement 10Labeling · Standard review	Approved	None posted
Oct 13, 1977	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 13, 1977	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 9, 1971	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 16862
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