Synacort

ANDA 87459, held by Bausch. Hydrocortisone.

As of Nov 13, 2026, ANDA 87459 (Synacort), held by Bausch, was first approved by FDA on Jun 23, 1981, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 23, 1981
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 23, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Synacort0.5% · cream;topical	Hydrocortisone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 17, 1983	Supplement 1Manufacturing	Approved	None posted
Jun 23, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87459
Drugs@FDA: Overview at FDA
Company: Bausch Health

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