Fludarabine Phosphate

ANDA 77790, held by Hospira. Fludarabine Phosphate.

As of Nov 15, 2026, ANDA 77790 (Fludarabine Phosphate), held by Hospira, was first approved by FDA on Apr 6, 2007, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 6, 2007
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
Apr 6, 2007	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Jun 22, 2009	Supplement 3Labeling	Approved	None posted
Jun 28, 2008	Supplement 1Labeling	Approved	None posted
Apr 6, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77790
Drugs@FDA: Overview at FDA
Company: Hospira

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