Prednisolone

ANDA 80327, held by Roxane. Prednisolone.

As of Nov 15, 2026, ANDA 80327 (Prednisolone), held by Roxane, was first approved by FDA on Nov 24, 1971, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 24, 1971
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 24, 1971	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisolone5MG · tablet;oral	Prednisolone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 15, 1991	Supplement 17Labeling	Approved	None posted
Nov 24, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 80327
Drugs@FDA: Overview at FDA
Company: Roxane 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