Prednisolone

ANDA 40401, held by Hikma. Prednisolone.

As of Nov 15, 2026, ANDA 40401 (Prednisolone), held by Hikma, was first approved by FDA on Feb 27, 2003, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 27, 2003
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Feb 27, 2003	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Sep 29, 2011	Supplement 4Labeling	Approved	None posted
May 29, 2009	Supplement 2Labeling	Approved	None posted
Feb 27, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40401
Drugs@FDA: Overview at FDA
Company: Hikma

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