Prednisone

As of Nov 14, 2026, ANDA 89984 (Prednisone), held by Rising, was first approved by FDA on Jan 12, 1989, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 12, 1989
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
Jan 12, 1989	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


May 9, 2001	Supplement 7Manufacturing	Approved	None posted
Feb 8, 1994	Supplement 5Labeling	Approved	None posted
Jan 24, 1994	Supplement 4Manufacturing	Approved	None posted
Oct 15, 1992	Supplement 3Manufacturing	Approved	None posted
Aug 3, 1989	Supplement 1Labeling	Approved	None posted
Jan 12, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 89984
Drugs@FDA: Overview at FDA
Company: Rising 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