Neo-Cort-Dome

NDA 50238, held by Bayer Pharms. Acetic Acid, Glacial; Hydrocortisone; Neomycin Sulfate.

As of Nov 13, 2026, NDA 50238 (Neo-Cort-Dome), held by Bayer Pharms, was first approved by FDA on Dec 14, 1966, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 14, 1966
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 14, 1966	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Neo-Cort-Dome2%;1%;EQ 0.35% BASE · suspension/drops;otic	Acetic Acid, Glacial; Hydrocortisone; Neomycin Sulfate	Discontinued

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 22, 1982	Supplement 1Labeling	Approved	None posted
Apr 6, 1982	Supplement 8Manufacturing	Approved	None posted
May 21, 1981	Supplement 6Manufacturing	Approved	None posted
Dec 14, 1966	Original application	Approved	None posted

Identifiers

Application: NDA 50238
Drugs@FDA: Overview at FDA
Company: Bayer Pharms

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