Meticortelone

NDA 10255, held by Schering. Prednisolone Acetate.

As of Nov 13, 2026, NDA 10255 (Meticortelone), held by Schering, was first approved by FDA on May 22, 1955, with 1 approved supplement and 0 published complete response letters.

First approved: May 22, 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
May 22, 1955	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meticortelone25MG/ML · injectable;injection	Prednisolone Acetate	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 1, 1978	Supplement 3Labeling · Standard review	Approved	None posted
May 22, 1955	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 10255
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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