Prednisone

ANDA 88396, held by Duramed Pharms Barr. Prednisone.

As of Nov 14, 2026, ANDA 88396 (Prednisone), held by Duramed Pharms Barr, was first approved by FDA on Oct 4, 1983, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 4, 1983
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
Oct 4, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone20MG · tablet;oral	Prednisone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


May 2, 1989	Supplement 12Labeling	Approved	None posted
Dec 15, 1988	Supplement 11Labeling	Approved	None posted
Oct 4, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88396
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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