Adrucil

ANDA 81225, held by Teva Parenteral. Fluorouracil.

As of Nov 14, 2026, ANDA 81225 (Adrucil), held by Teva Parenteral, was first approved by FDA on Aug 28, 1991, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 28, 1991
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
Aug 28, 1991	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Jul 30, 1999	Supplement 5Labeling	Approved	None posted
Sep 12, 1997	Supplement 4Labeling	Approved	None posted
Nov 4, 1992	Supplement 3Manufacturing	Approved	None posted
Jul 10, 1992	Supplement 2Manufacturing	Approved	None posted
Dec 6, 1991	Supplement 1Labeling	Approved	None posted
Aug 28, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 81225
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