Fluorouracil

ANDA 203608, held by Sagent Pharms Inc. Fluorouracil.

As of Nov 15, 2026, ANDA 203608 (Fluorouracil), held by Sagent Pharms Inc, was first approved by FDA on May 11, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: May 11, 2017
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, 2017	Original application	Approved	None posted

Products

2 strengths and forms


Fluorouracil500MG/10ML (50MG/ML) · injectable;injection	Fluorouracil	Rx
Fluorouracil1GM/20ML (50MG/ML) · injectable;injection	Fluorouracil	Rx

All 3 submissions, including labeling and manufacturing supplements


Feb 5, 2026	Supplement 4Labeling · Standard review	Approved	Letter Label Label
Mar 21, 2024	Supplement 3Labeling · Standard review	Approved	Label Letter
May 11, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 203608
Drugs@FDA: Overview at FDA
Company: Sagent Pharmaceuticals

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