Prednisone

As of Nov 14, 2026, NDA 17109 (Prednisone), held by Roxane, was first approved by FDA on Jun 28, 1974, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 28, 1974
Review: Standard
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
Jun 28, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prednisone20MG · tablet;oral	Prednisone	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Apr 14, 1980	Supplement 10Labeling · Standard review	Approved	None posted
Nov 1, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 27, 1978	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 21, 1977	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 28, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17109
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