Darvon-N W/ Asa

NDA 16863, held by Aaipharma LLC. Aspirin; Propoxyphene Napsylate.

As of Nov 14, 2026, NDA 16863 (Darvon-N W/ Asa), held by Aaipharma LLC, was first approved by FDA on Sep 9, 1971, with 15 approved supplements and 0 published complete response letters.

First approved: Sep 9, 1971
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Sep 9, 1971	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Darvon-N W/ Asa325MG;100MG · tablet;oral	Aspirin; Propoxyphene Napsylate	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Aug 23, 1994	Supplement 24Labeling · Standard review	Approved	None posted
Sep 15, 1992	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 15, 1987	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 16, 1986	Supplement 18Labeling · Standard review	Approved	None posted
Apr 21, 1986	Supplement 15Labeling · Standard review	Approved	None posted
Aug 20, 1984	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 28, 1981	Supplement 13Labeling · Standard review	Approved	None posted
May 20, 1981	Supplement 12Labeling · Standard review	Approved	None posted
Apr 15, 1980	Supplement 11Labeling · Standard review	Approved	None posted
Jan 21, 1980	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 11, 1980	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 26, 1979	Supplement 10Labeling · Standard review	Approved	None posted
Jan 11, 1978	Supplement 8Labeling · Standard review	Approved	None posted
Oct 13, 1977	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 13, 1977	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 9, 1971	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16863
Drugs@FDA: Overview at FDA
Company: aaiPharma LLC

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