Neggram

NDA 14214, held by Sanofi Aventis US. Nalidixic Acid.

As of Nov 14, 2026, NDA 14214 (Neggram), held by Sanofi Aventis US, was first approved by FDA on Mar 6, 1964, with 36 approved supplements and 0 published complete response letters.

First approved: Mar 6, 1964
Review: Priority
Supplements approved: 36
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 37 submissions below

Date	Submission	Status	Documents
Mar 6, 1964	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


Neggram250MG · tablet;oral	Nalidixic Acid	Discontinued
Neggram500MG · tablet;oral	Nalidixic Acid	Discontinued
Neggram1GM · tablet;oral	Nalidixic Acid	Discontinued

All 37 submissions, including labeling and manufacturing supplements


Nov 28, 2012	Supplement 60Labeling · Standard review	Approved	Label Letter
Apr 29, 2011	Supplement 59Labeling	Approved	Letter Label
Mar 28, 2009	Supplement 58Labeling · Standard review	Approved	Label Letter
May 24, 2007	Supplement 57Labeling · Standard review	Approved	Letter Label
Sep 7, 2004	Supplement 56Labeling · Standard review	Approved	Letter Label
Sep 7, 2004	Supplement 55Labeling · Standard review	Approved	Letter Label
Sep 7, 2004	Supplement 53Labeling · Standard review	Approved	Letter Label
Sep 20, 2002	Supplement 52Manufacturing · Priority review	Approved	None posted
Nov 23, 1999	Supplement 51Labeling · Standard review	Approved	Review
Nov 23, 1999	Supplement 50Labeling · Standard review	Approved	Review
Oct 3, 1995	Supplement 49Manufacturing · Priority review	Approved	None posted
Feb 7, 1995	Supplement 44Labeling	Approved	None posted
Jun 24, 1991	Supplement 48Manufacturing · Priority review	Approved	None posted
Oct 5, 1990	Supplement 46Manufacturing · Priority review	Approved	None posted
Sep 17, 1990	Supplement 47Manufacturing · Priority review	Approved	None posted
Jul 20, 1990	Supplement 45Manufacturing · Priority review	Approved	None posted
Apr 28, 1986	Supplement 42Labeling	Approved	None posted
Mar 21, 1986	Supplement 43Manufacturing · Priority review	Approved	None posted
Aug 17, 1983	Supplement 40Manufacturing · Priority review	Approved	None posted
Aug 18, 1981	Supplement 38Manufacturing · Priority review	Approved	None posted
Aug 18, 1981	Supplement 35Manufacturing · Priority review	Approved	None posted
Jun 4, 1981	Supplement 37Manufacturing · Priority review	Approved	None posted
Jun 4, 1981	Supplement 36Manufacturing · Priority review	Approved	None posted
Feb 23, 1981	Supplement 30Labeling	Approved	None posted
Dec 12, 1980	Supplement 34Labeling	Approved	None posted
Apr 9, 1980	Supplement 33Manufacturing · Priority review	Approved	None posted
Feb 13, 1979	Supplement 32Manufacturing · Priority review	Approved	None posted
Jul 11, 1978	Supplement 31Manufacturing · Priority review	Approved	None posted
May 3, 1978	Supplement 29Labeling	Approved	None posted
Jun 29, 1977	Supplement 26Manufacturing · Priority review	Approved	None posted
Feb 23, 1977	Supplement 20	Approved	None posted
Apr 8, 1976	Supplement 23Manufacturing · Priority review	Approved	None posted
Mar 31, 1976	Supplement 24Labeling	Approved	None posted
Sep 8, 1975	Supplement 22Manufacturing · Priority review	Approved	None posted
Jul 18, 1975	Supplement 21Manufacturing · Priority review	Approved	None posted
Feb 26, 1975	Supplement 14	Approved	None posted
Mar 6, 1964	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 14214
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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