Fludarabine Phosphate

ANDA 76349, held by Hikma. Fludarabine Phosphate.

As of Nov 15, 2026, ANDA 76349 (Fludarabine Phosphate), held by Hikma, was first approved by FDA on Aug 28, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 28, 2003
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
Aug 28, 2003	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fludarabine Phosphate50MG/VIAL · injectable;injection	Fludarabine Phosphate	Rx

All 3 submissions, including labeling and manufacturing supplements


Dec 8, 2011	Supplement 14Labeling	Approved	None posted
Mar 21, 2011	Supplement 4Labeling	Approved	None posted
Aug 28, 2003	Original application	Approved	Review

Identifiers

Application: ANDA 76349
Drugs@FDA: Overview at FDA
Company: Hikma

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