Prelone

As of Nov 15, 2026, ANDA 89654 (Prelone), held by Muro, was first approved by FDA on Jan 17, 1989, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 17, 1989
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 17, 1989	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prelone5MG/5ML · syrup;oral	Prednisolone	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Dec 9, 2002	Supplement 9Manufacturing	Approved	None posted
Jul 28, 1998	Supplement 8Labeling	Approved	None posted
Apr 1, 1998	Supplement 7Labeling	Approved	None posted
Jun 23, 1994	Supplement 5Labeling	Approved	None posted
Jul 2, 1993	Supplement 1Manufacturing	Approved	None posted
Jul 2, 1993	Supplement 2Manufacturing	Approved	None posted
Jul 2, 1993	Supplement 3Labeling	Approved	None posted
Jan 17, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 89654
Drugs@FDA: Overview at FDA
Company: Muro Pharmaceutical

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