Prednisone

As of Nov 14, 2026, ANDA 85813 (Prednisone), held by Rising, was first approved by FDA on May 31, 1978, with 20 approved supplements and 0 published complete response letters.

First approved: May 31, 1978
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
May 31, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone20MG · tablet;oral	Prednisone	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Apr 10, 1995	Supplement 30Manufacturing	Approved	None posted
Feb 5, 1991	Supplement 29Manufacturing	Approved	None posted
Aug 3, 1989	Supplement 28Labeling	Approved	None posted
Aug 12, 1987	Supplement 27Manufacturing	Approved	None posted
Feb 11, 1987	Supplement 26Manufacturing	Approved	None posted
Aug 1, 1986	Supplement 24Manufacturing	Approved	None posted
Aug 1, 1986	Supplement 23Manufacturing	Approved	None posted
Aug 1, 1986	Supplement 22Manufacturing	Approved	None posted
Aug 1, 1986	Supplement 21Manufacturing	Approved	None posted
Jan 16, 1986	Supplement 20Manufacturing	Approved	None posted
Jan 16, 1986	Supplement 19Manufacturing	Approved	None posted
Jan 16, 1986	Supplement 18Manufacturing	Approved	None posted
Feb 27, 1985	Supplement 13Manufacturing	Approved	None posted
Sep 21, 1984	Supplement 12Manufacturing	Approved	None posted
Sep 21, 1984	Supplement 11Manufacturing	Approved	None posted
Nov 16, 1982	Supplement 10Manufacturing	Approved	None posted
Jun 18, 1982	Supplement 9Manufacturing	Approved	None posted
Jun 18, 1982	Supplement 8Manufacturing	Approved	None posted
Jun 18, 1982	Supplement 3Manufacturing	Approved	None posted
Jun 18, 1982	Supplement 2Manufacturing	Approved	None posted
May 31, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85813
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