Prednisone

ANDA 89726, held by Xttrium Labs Inc. Prednisone.

As of Nov 14, 2026, ANDA 89726 (Prednisone), held by Xttrium Labs Inc, was first approved by FDA on Aug 2, 1988, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 2, 1988
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 2, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone5MG/5ML · solution;oral	Prednisone	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Aug 2, 1993	Supplement 3Manufacturing	Approved	None posted
Jun 26, 1992	Supplement 4Labeling	Approved	None posted
Oct 24, 1989	Supplement 2Labeling	Approved	None posted
Aug 2, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89726
Drugs@FDA: Overview at FDA
Company: Xttrium Laboratories

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