Dolobid

As of Nov 14, 2026, NDA 18445 (Dolobid), held by Merck, was first approved by FDA on Apr 19, 1982, with 43 approved supplements and 0 published complete response letters.

First approved: Apr 19, 1982
Review: Priority
Supplements approved: 43
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 44 submissions below

Date	Submission	Status	Documents
Apr 19, 1982	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Dolobid250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Diflunisal	DiscontinuedReference drug
Dolobid500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Diflunisal	DiscontinuedReference drug

All 44 submissions, including labeling and manufacturing supplements


Mar 16, 2007	Supplement 58Labeling · Priority review	Approved	Letter Label
Jan 24, 2006	Supplement 57Labeling · Priority review	Approved	Letter Label
May 15, 1998	Supplement 53Labeling · Priority review	Approved	None posted
May 15, 1998	Supplement 52Labeling · Priority review	Approved	None posted
Dec 1, 1997	Supplement 54Manufacturing · Priority review	Approved	None posted
Apr 17, 1997	Supplement 50Labeling · Priority review	Approved	None posted
Mar 1, 1996	Supplement 51Manufacturing · Priority review	Approved	None posted
Aug 22, 1994	Supplement 48Labeling · Priority review	Approved	None posted
Aug 22, 1994	Supplement 47Labeling · Priority review	Approved	None posted
Aug 22, 1994	Supplement 46Labeling · Priority review	Approved	None posted
Aug 18, 1994	Supplement 49Manufacturing · Priority review	Approved	None posted
Mar 28, 1994	Supplement 28Manufacturing · Priority review	Approved	None posted
Dec 6, 1991	Supplement 44Labeling · Priority review	Approved	None posted
Dec 6, 1991	Supplement 43Manufacturing · Priority review	Approved	None posted
Nov 19, 1991	Supplement 42Manufacturing · Priority review	Approved	None posted
Apr 21, 1989	Supplement 37Manufacturing · Priority review	Approved	None posted
Apr 21, 1989	Supplement 22Manufacturing · Priority review	Approved	None posted
Jan 9, 1989	Supplement 40Labeling · Priority review	Approved	None posted
Jan 9, 1989	Supplement 38Manufacturing · Priority review	Approved	None posted
Jan 9, 1989	Supplement 36Labeling · Priority review	Approved	None posted
May 3, 1988	Supplement 35Manufacturing · Priority review	Approved	None posted
Feb 2, 1988	Supplement 34Labeling · Priority review	Approved	None posted
Feb 2, 1988	Supplement 33Labeling · Priority review	Approved	None posted
Feb 2, 1988	Supplement 32Labeling · Priority review	Approved	None posted
Feb 2, 1988	Supplement 31Labeling · Priority review	Approved	None posted
Feb 2, 1988	Supplement 30Labeling · Priority review	Approved	None posted
Feb 2, 1988	Supplement 27Labeling · Priority review	Approved	None posted
Feb 2, 1988	Supplement 24Labeling · Priority review	Approved	None posted
Aug 15, 1986	Supplement 26Labeling · Priority review	Approved	None posted
Aug 15, 1986	Supplement 25Labeling · Priority review	Approved	None posted
Feb 3, 1986	Supplement 21Manufacturing · Priority review	Approved	None posted
Feb 3, 1986	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 30, 1985	Supplement 19Manufacturing · Priority review	Approved	None posted
Feb 21, 1985	Supplement 18Manufacturing · Priority review	Approved	None posted
Feb 21, 1985	Supplement 17Manufacturing · Priority review	Approved	None posted
Jan 9, 1985	Supplement 8Labeling · Priority review	Approved	None posted
Dec 11, 1984	Supplement 12Manufacturing · Priority review	Approved	None posted
Nov 20, 1984	Supplement 16Manufacturing · Priority review	Approved	None posted
Oct 3, 1984	Supplement 15Manufacturing · Priority review	Approved	None posted
Jun 25, 1984	Supplement 9Manufacturing · Priority review	Approved	None posted
May 3, 1984	Supplement 10Manufacturing · Priority review	Approved	None posted
Oct 27, 1983	Supplement 7Labeling · Priority review	Approved	None posted
Oct 27, 1983	Supplement 3Labeling · Priority review	Approved	None posted
Apr 19, 1982	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 18445
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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