Nitrofurantoin

ANDA 205180, held by Actavis Mid Atlantic. Nitrofurantoin.

As of Nov 14, 2026, ANDA 205180 (Nitrofurantoin), held by Actavis Mid Atlantic, was first approved by FDA on May 3, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: May 3, 2016
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 3, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nitrofurantoin25MG/5ML · suspension;oral	Nitrofurantoin	Rx

All 3 submissions, including labeling and manufacturing supplements


Nov 12, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Nov 12, 2024	Supplement 4Labeling · Standard review	Approved	None posted
May 3, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 205180
Drugs@FDA: Overview at FDA
Company: Actavis Mid Atlantic LLC

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