Neggram

NDA 17430, held by Sanofi Aventis US. Nalidixic Acid.

As of Nov 13, 2026, NDA 17430 (Neggram), held by Sanofi Aventis US, was first approved by FDA on Apr 17, 1973, with 31 approved supplements and 0 published complete response letters.

First approved: Apr 17, 1973
Review: Standard
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Apr 17, 1973	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Neggram250MG/5ML · suspension;oral	Nalidixic Acid	Discontinued

All 32 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 31Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 14Labeling	Approved	None posted
Dec 7, 2007	Supplement 8Labeling	Approved	None posted
Dec 7, 2007	Supplement 5Labeling	Approved	None posted
Aug 3, 2007	Supplement 32Labeling · Standard review	Approved	Letter Label
Sep 7, 2004	Supplement 30Labeling · Standard review	Approved	Letter Label
Sep 7, 2004	Supplement 29Labeling · Standard review	Approved	Letter Label
Sep 7, 2004	Supplement 28Labeling · Standard review	Approved	Label Letter
Nov 23, 1999	Supplement 27Labeling · Standard review	Approved	Review
Nov 23, 1999	Supplement 26Labeling · Standard review	Approved	Review
Feb 7, 1995	Supplement 19Labeling	Approved	None posted
Oct 31, 1994	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 3, 1993	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 24, 1991	Supplement 23Manufacturing · Standard review	Approved	None posted
May 13, 1991	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 30, 1990	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 13, 1990	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 14, 1988	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 21, 1987	Supplement 16Labeling	Approved	None posted
Apr 21, 1986	Supplement 17Labeling	Approved	None posted
Feb 6, 1984	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 2, 1983	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 18, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 23, 1981	Supplement 10Labeling	Approved	None posted
Jun 30, 1980	Supplement 11Labeling	Approved	None posted
Jul 1, 1977	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 23, 1977	Supplement 7Labeling	Approved	None posted
Sep 23, 1976	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 8, 1976	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 13, 1975	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 28, 1975	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 17, 1973	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17430
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