Delta-Cortef

NDA 9987, held by Pharmacia And Upjohn. Prednisolone.

As of Nov 13, 2026, NDA 9987 (Delta-Cortef), held by Pharmacia And Upjohn, was first approved by FDA on Jun 21, 1955, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 21, 1955
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 21, 1955	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Delta-Cortef5MG · tablet;oral	Prednisolone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 25, 1978	Supplement 19Labeling · Standard review	Approved	None posted
Jun 21, 1955	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 9987
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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