Macrodantin

Treats urinary tract infections. NDA 16620, held by Almatica. Nitrofurantoin, Macrocrystalline.

As of Nov 13, 2026, NDA 16620 (Macrodantin), held by Almatica, was first approved by FDA on Jun 5, 1970, with 45 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1970
Review: Standard
Supplements approved: 45
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Nitrofurantoin Macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Macrocrystals and other antibacterial drugs, Nitrofurantoin Macrocrystals should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 46 submissions below

Date	Submission	Status	Documents
Jun 5, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Macrodantin50MG · capsule;oral	Nitrofurantoin, Macrocrystalline	DiscontinuedReference drug
Macrodantin100MG · capsule;oral	Nitrofurantoin, Macrocrystalline	DiscontinuedReference drug
Macrodantin25MG · capsule;oral	Nitrofurantoin, Macrocrystalline	DiscontinuedReference drug

All 46 submissions, including labeling and manufacturing supplements


Jan 21, 2021	Supplement 76Labeling · Standard review	Approved	Label Letter
Oct 15, 2015	Supplement 74Manufacturing · Standard review	Approved	None posted
Oct 2, 2015	Supplement 73Manufacturing · Standard review	Approved	None posted
Sep 6, 2013	Supplement 72Labeling · Standard review	Approved	Letter Label
Jun 6, 2011	Supplement 70Labeling · Standard review	Approved	Letter
Mar 5, 2009	Supplement 68Labeling · Standard review	Approved	Label Letter
Sep 14, 2007	Supplement 67Labeling · Standard review	Approved	Letter Label
Mar 29, 2004	Supplement 65Labeling · Standard review	Approved	Review Letter Label
Feb 4, 2003	Supplement 64Labeling · Standard review	Approved	Review Letter
Oct 21, 1998	Supplement 63Manufacturing · Standard review	Approved	Review
Feb 17, 1998	Supplement 58Labeling · Standard review	Approved	None posted
Feb 17, 1998	Supplement 56Labeling · Standard review	Approved	None posted
Jul 16, 1997	Supplement 62Labeling · Standard review	Approved	Review
Mar 27, 1997	Supplement 61Labeling · Standard review	Approved	None posted
Jul 30, 1996	Supplement 60Manufacturing · Standard review	Approved	None posted
Mar 7, 1996	Supplement 59Manufacturing · Standard review	Approved	Review
Aug 9, 1993	Supplement 57Manufacturing · Standard review	Approved	Review
May 19, 1993	Supplement 39Labeling	Approved	None posted
May 18, 1993	Supplement 36Labeling	Approved	None posted
Dec 8, 1992	Supplement 55Manufacturing · Standard review	Approved	Review
Dec 8, 1992	Supplement 54Manufacturing · Standard review	Approved	Review
Dec 8, 1992	Supplement 53Manufacturing · Standard review	Approved	Review
Dec 8, 1992	Supplement 52Manufacturing · Standard review	Approved	None posted
Apr 10, 1991	Supplement 51Manufacturing · Standard review	Approved	None posted
Sep 11, 1990	Supplement 49Manufacturing · Standard review	Approved	None posted
Jul 9, 1990	Supplement 50Manufacturing · Standard review	Approved	None posted
Jan 3, 1989	Supplement 47Manufacturing · Standard review	Approved	Review
May 13, 1988	Supplement 45Labeling	Approved	Review
Jul 9, 1984	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 2, 1983	Supplement 37Manufacturing · Standard review	Approved	None posted
Oct 15, 1982	Supplement 31Labeling	Approved	None posted
May 13, 1982	Supplement 35Manufacturing · Standard review	Approved	None posted
Dec 12, 1980	Supplement 32Labeling	Approved	None posted
Aug 14, 1980	Supplement 30Manufacturing · Standard review	Approved	None posted
May 20, 1980	Supplement 28Manufacturing · Standard review	Approved	None posted
Dec 18, 1979	Supplement 26Labeling	Approved	None posted
Jul 26, 1979	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 16, 1979	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 28, 1978	Supplement 23Labeling	Approved	None posted
May 13, 1977	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 21, 1977	Supplement 20Manufacturing · Standard review	Approved	Review
Nov 22, 1976	Supplement 19Manufacturing · Standard review	Approved	Review
Jul 21, 1976	Supplement 18Manufacturing · Standard review	Approved	Review
Jul 21, 1976	Supplement 17Manufacturing · Standard review	Approved	Review
Jul 15, 1976	Supplement 16Manufacturing · Standard review	Approved	Review
Jun 5, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16620
Drugs@FDA: Overview at FDA
Company: Almatica Pharma

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