Ansaid

NDA 18766, held by Pharmacia And Upjohn. Flurbiprofen.

As of Nov 14, 2026, NDA 18766 (Ansaid), held by Pharmacia And Upjohn, was first approved by FDA on Oct 31, 1988, with 12 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1988
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Oct 31, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Ansaid50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Flurbiprofen	DiscontinuedReference drug
Ansaid100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Flurbiprofen	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


May 9, 2016	Supplement 20Labeling · Standard review	Approved	Letter Label
Aug 13, 2010	Supplement 15Labeling	Approved	Letter Medication Guide Label
Jun 21, 2007	Supplement 14Labeling · Standard review	Approved	Letter
Jan 24, 2006	Supplement 13Labeling · Standard review	Approved	Letter Label
Oct 30, 2001	Supplement 11Labeling · Standard review	Approved	None posted
Oct 30, 2001	Supplement 10Labeling · Standard review	Approved	None posted
Dec 13, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 25, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 25, 1994	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 4, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 6, 1989	Supplement 2Manufacturing · Standard review	Approved	None posted
May 5, 1989	Supplement 1Labeling	Approved	None posted
Oct 31, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18766
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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