Prednisolone

ANDA 80780, held by Impax Labs. Prednisolone.

As of Nov 15, 2026, ANDA 80780 (Prednisolone), held by Impax Labs, was first approved by FDA on Jul 13, 1973, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 13, 1973
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 13, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisolone5MG · tablet;oral	Prednisolone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Mar 16, 2001	Supplement 39Labeling	Approved	None posted
Oct 18, 1996	Supplement 43Labeling	Approved	None posted
Oct 28, 1991	Supplement 41Labeling	Approved	None posted
Oct 28, 1991	Supplement 42Labeling	Approved	None posted
Dec 13, 1989	Supplement 40Labeling	Approved	None posted
Jul 13, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80780
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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