Prednisone

ANDA 84634, held by Mutual Pharm. Prednisone.

As of Nov 14, 2026, ANDA 84634 (Prednisone), held by Mutual Pharm, was first approved by FDA on Oct 21, 1975, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 21, 1975
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 21, 1975	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone20MG · tablet;oral	Prednisone	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 55Manufacturing	Approved	None posted
Apr 5, 1995	Supplement 52Labeling	Approved	None posted
Dec 23, 1994	Supplement 54Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 53Manufacturing	Approved	None posted
Apr 4, 1994	Supplement 51Labeling	Approved	None posted
Apr 3, 1992	Supplement 50Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 48Manufacturing	Approved	None posted
Mar 27, 1991	Supplement 47Labeling	Approved	None posted
Mar 31, 1987	Supplement 45Manufacturing	Approved	None posted
Nov 19, 1985	Supplement 41Manufacturing	Approved	None posted
Nov 19, 1985	Supplement 39Manufacturing	Approved	None posted
Nov 19, 1985	Supplement 38Manufacturing	Approved	None posted
Sep 30, 1982	Supplement 36Manufacturing	Approved	None posted
Dec 7, 1981	Supplement 32Manufacturing	Approved	None posted
Oct 21, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 84634
Drugs@FDA: Overview at FDA
Company: Mutual Pharmaceutical Company

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