Nitrofurantoin

ANDA 201679, held by Amneal Pharms. Nitrofurantoin.

First approved: May 11, 2011
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 11, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 28, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Jun 25, 2014	Supplement 1Labeling · Standard review	Approved	None posted
May 11, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 201679
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters