Nitrofurantoin

ANDA 85797, held by Watson Labs. Nitrofurantoin.

As of Nov 14, 2026, ANDA 85797 (Nitrofurantoin), held by Watson Labs, was first approved by FDA on Dec 5, 1978, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 5, 1978
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
Dec 5, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nitrofurantoin50MG · tablet;oral	Nitrofurantoin	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 8, 1989	Supplement 17Labeling	Approved	None posted
Dec 5, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85797
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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