Prednisone

ANDA 84913, held by Whiteworth Town Plsn. Prednisone.

As of Nov 14, 2026, ANDA 84913 (Prednisone), held by Whiteworth Town Plsn, was first approved by FDA on Jul 17, 1978, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 17, 1978
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jul 17, 1978	Original application	Approved	None posted

Products

2 strengths and forms


Prednisone2.5MG · tablet;oral	Prednisone	Discontinued
Prednisone20MG · tablet;oral	Prednisone	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jan 7, 1987	Supplement 7Manufacturing	Approved	None posted
Jan 7, 1987	Supplement 8Manufacturing	Approved	None posted
May 14, 1986	Supplement 4Manufacturing	Approved	None posted
May 14, 1986	Supplement 6Manufacturing	Approved	None posted
Jul 17, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 84913
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