Prednisolone

ANDA 80342, held by Whiteworth Town Plsn. Prednisolone.

As of Nov 15, 2026, ANDA 80342 (Prednisolone), held by Whiteworth Town Plsn, was first approved by FDA on Jun 20, 1973, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 20, 1973
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 20, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisolone5MG · tablet;oral	Prednisolone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Nov 26, 1985	Supplement 5Manufacturing	Approved	None posted
Nov 26, 1985	Supplement 6Manufacturing	Approved	None posted
Jun 20, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80342
Drugs@FDA: Overview at FDA
Company: Whiteworth Town Plsn

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