Orabase Hca

ANDA 83205, held by Colgate. Hydrocortisone Acetate.

As of Nov 15, 2026, ANDA 83205 (Orabase Hca), held by Colgate, was first approved by FDA on Mar 6, 1973, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 6, 1973
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
Mar 6, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Orabase Hca0.5% · paste;topical	Hydrocortisone Acetate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Sep 11, 1990	Supplement 17Labeling	Approved	None posted
Nov 22, 1985	Supplement 15Manufacturing	Approved	None posted
Aug 10, 1984	Supplement 12Manufacturing	Approved	None posted
Mar 6, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 83205
Drugs@FDA: Overview at FDA
Company: Colgate

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