Furalan

ANDA 80017, held by Chartwell Molecular. Nitrofurantoin.

As of Nov 14, 2026, ANDA 80017 (Furalan), held by Chartwell Molecular, was first approved by FDA on Sep 30, 1970, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 30, 1970
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 30, 1970	Original application	Approved	None posted

Products

2 strengths and forms


Furalan50MG · tablet;oral	Nitrofurantoin	Discontinued
Furalan100MG · tablet;oral	Nitrofurantoin	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 25, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Sep 30, 1970	Original application	Approved	None posted

Identifiers

Application: ANDA 80017
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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