Prednisone

ANDA 80701, held by Mutual Pharm. Prednisone.

As of Nov 14, 2026, ANDA 80701 (Prednisone), held by Mutual Pharm, was first approved by FDA on Nov 14, 1972, with 12 approved supplements and 0 published complete response letters.

First approved: Nov 14, 1972
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Nov 14, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone5MG · tablet;oral	Prednisone	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 88Manufacturing	Approved	None posted
Apr 5, 1995	Supplement 85Labeling	Approved	None posted
Jan 12, 1995	Supplement 79Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 87Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 86Manufacturing	Approved	None posted
Apr 4, 1994	Supplement 84Labeling	Approved	None posted
Apr 3, 1992	Supplement 83Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 81Manufacturing	Approved	None posted
Apr 5, 1991	Supplement 78Labeling	Approved	None posted
Apr 5, 1991	Supplement 77Manufacturing	Approved	None posted
Mar 2, 1989	Supplement 76Labeling	Approved	None posted
Feb 5, 1986	Supplement 71Manufacturing	Approved	None posted
Nov 14, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80701
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