Synacort

ANDA 87457, held by Bausch. Hydrocortisone.

As of Nov 13, 2026, ANDA 87457 (Synacort), held by Bausch, was first approved by FDA on Jun 23, 1981, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1981
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 23, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Synacort2.5% · cream;topical	Hydrocortisone	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Feb 27, 1992	Supplement 7Labeling	Approved	None posted
Jun 2, 1987	Supplement 5Manufacturing	Approved	None posted
Feb 17, 1983	Supplement 2Manufacturing	Approved	None posted
Feb 17, 1983	Supplement 1Manufacturing	Approved	None posted
Jun 23, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87457
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