Fludarabine Phosphate

ANDA 203738, held by Actavis LLC. Fludarabine Phosphate.

As of Nov 15, 2026, ANDA 203738 (Fludarabine Phosphate), held by Actavis LLC, was first approved by FDA on Feb 28, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 28, 2017
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
Feb 28, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fludarabine Phosphate50MG/2ML (25MG/ML) · injectable;injection	Fludarabine Phosphate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 1, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Feb 28, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 203738
Drugs@FDA: Overview at FDA
Company: Actavis

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