Prednisone

ANDA 80343, held by Whiteworth Town Plsn. Prednisone.

As of Nov 14, 2026, ANDA 80343 (Prednisone), 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
Prednisone5MG · tablet;oral	Prednisone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 15, 1986	Supplement 13Manufacturing	Approved	None posted
Jan 15, 1986	Supplement 15Manufacturing	Approved	None posted
Jun 20, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80343
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