Prednisone

ANDA 88465, held by Hikma Pharms. Prednisone.

As of Nov 14, 2026, ANDA 88465 (Prednisone), held by Hikma Pharms, was first approved by FDA on Jun 1, 1984, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 1, 1984
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 1, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone50MG · tablet;oral	Prednisone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 9Labeling · Standard review	Approved	None posted
May 29, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Nov 14, 1994	Supplement 5Labeling	Approved	None posted
Feb 9, 1994	Supplement 4Labeling	Approved	None posted
Dec 16, 1991	Supplement 3Manufacturing	Approved	None posted
Jun 1, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88465
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