Prednisone

ANDA 40538, held by Hikma Pharms. Prednisone.

As of Nov 14, 2026, ANDA 40538 (Prednisone), held by Hikma Pharms, was first approved by FDA on Jan 8, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 8, 2004
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
Jan 8, 2004	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone2.5MG · tablet;oral	Prednisone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 7Labeling · Standard review	Approved	None posted
May 10, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jan 8, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 40538
Drugs@FDA: Overview at FDA
Company: Hikma 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