Prelone

As of Nov 15, 2026, ANDA 89081 (Prelone), held by Teva, was first approved by FDA on Feb 4, 1986, with 22 approved supplements and 0 published complete response letters.

First approved: Feb 4, 1986
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Feb 4, 1986	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prelone15MG/5ML · solution;oral	Prednisolone	Rx

All 23 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 40Labeling · Standard review	Approved	None posted
Dec 9, 2002	Supplement 23Manufacturing	Approved	None posted
Sep 11, 2002	Supplement 22Labeling	Approved	None posted
Sep 11, 2002	Supplement 21Labeling	Approved	None posted
Aug 5, 1998	Supplement 20Labeling	Approved	None posted
Jun 29, 1998	Supplement 19Manufacturing	Approved	None posted
May 15, 1998	Supplement 18Labeling	Approved	None posted
Jul 28, 1997	Supplement 17Manufacturing	Approved	None posted
May 12, 1994	Supplement 15Labeling	Approved	None posted
May 10, 1994	Supplement 16Manufacturing	Approved	None posted
Oct 15, 1993	Supplement 14Manufacturing	Approved	None posted
Sep 3, 1992	Supplement 12Manufacturing	Approved	None posted
Sep 3, 1992	Supplement 11Manufacturing	Approved	None posted
Sep 3, 1992	Supplement 10Labeling	Approved	None posted
Jul 6, 1992	Supplement 13Labeling	Approved	None posted
May 10, 1991	Supplement 9Manufacturing	Approved	None posted
Jan 28, 1988	Supplement 8Manufacturing	Approved	None posted
Jan 28, 1988	Supplement 7Manufacturing	Approved	None posted
Jan 28, 1988	Supplement 6Manufacturing	Approved	None posted
Mar 24, 1987	Supplement 5Manufacturing	Approved	None posted
Mar 24, 1987	Supplement 4Manufacturing	Approved	None posted
May 15, 1986	Supplement 3Manufacturing	Approved	None posted
Feb 4, 1986	Original application	Approved	Review

Identifiers

Application: ANDA 89081
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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