Prednisone

ANDA 86595, held by Mutual Pharm. Prednisone.

As of Nov 14, 2026, ANDA 86595 (Prednisone), held by Mutual Pharm, was first approved by FDA on Apr 10, 1979, with 14 approved supplements and 0 published complete response letters.

First approved: Apr 10, 1979
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
Apr 10, 1979	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone10MG · tablet;oral	Prednisone	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 35Manufacturing	Approved	None posted
Apr 5, 1995	Supplement 32Labeling	Approved	None posted
Dec 23, 1994	Supplement 34Manufacturing	Approved	None posted
Dec 12, 1994	Supplement 27Labeling	Approved	None posted
Dec 12, 1994	Supplement 26Manufacturing	Approved	None posted
Dec 12, 1994	Supplement 25Manufacturing	Approved	None posted
Dec 12, 1994	Supplement 24Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 33Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 29Manufacturing	Approved	None posted
Feb 19, 1991	Supplement 28Labeling	Approved	None posted
Apr 1, 1987	Supplement 22Manufacturing	Approved	None posted
Jan 17, 1986	Supplement 17Manufacturing	Approved	None posted
Jan 17, 1986	Supplement 16Manufacturing	Approved	None posted
Jan 17, 1986	Supplement 15Manufacturing	Approved	None posted
Apr 10, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 86595
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