Prednisolone

ANDA 40287, held by Ivax Sub Teva Pharms. Prednisolone.

As of Nov 15, 2026, ANDA 40287 (Prednisolone), held by Ivax Sub Teva Pharms, was first approved by FDA on May 28, 1999, with 8 approved supplements and 0 published complete response letters.

First approved: May 28, 1999
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
May 28, 1999	Original application	Approved	Label Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisolone15MG/5ML · solution;oral	Prednisolone	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Nov 8, 2002	Supplement 7Manufacturing	Approved	None posted
Nov 8, 2002	Supplement 8Manufacturing	Approved	None posted
Feb 8, 2002	Supplement 6Manufacturing	Approved	None posted
Nov 2, 2001	Supplement 5Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 1Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 2Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 3Manufacturing	Approved	None posted
Dec 18, 2000	Supplement 4Manufacturing	Approved	None posted
May 28, 1999	Original application	Approved	Label Review Letter

Identifiers

Application: ANDA 40287
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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