Adrucil

ANDA 40023, held by Teva Parenteral. Fluorouracil.

As of Nov 14, 2026, ANDA 40023 (Adrucil), held by Teva Parenteral, was first approved by FDA on Oct 18, 1991, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 18, 1991
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Oct 18, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Adrucil50MG/ML · injectable;injection	Fluorouracil	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Sep 13, 1999	Supplement 6Labeling	Approved	None posted
Sep 12, 1997	Supplement 4Labeling	Approved	None posted
Nov 4, 1992	Supplement 3Manufacturing	Approved	None posted
Jul 10, 1992	Supplement 1Manufacturing	Approved	None posted
Oct 18, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 40023
Drugs@FDA: Overview at FDA
Company: Teva Parenteral Medicines

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