Nitrofurantoin

ANDA 85796, held by Watson Labs. Nitrofurantoin.

As of Nov 14, 2026, ANDA 85796 (Nitrofurantoin), held by Watson Labs, was first approved by FDA on Nov 22, 1978, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 22, 1978
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Nov 22, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nitrofurantoin100MG · tablet;oral	Nitrofurantoin	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Feb 8, 1989	Supplement 11Labeling	Approved	None posted
Mar 18, 1986	Supplement 9Manufacturing	Approved	None posted
May 6, 1983	Supplement 6Manufacturing	Approved	None posted
May 25, 1982	Supplement 4Manufacturing	Approved	None posted
Oct 22, 1981	Supplement 5Manufacturing	Approved	None posted
Nov 22, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85796
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