Carmol Hc

ANDA 80505, held by Fougera Pharms. Hydrocortisone Acetate.

As of Nov 15, 2026, ANDA 80505 (Carmol Hc), held by Fougera Pharms, was first approved by FDA on Jan 12, 1973, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 12, 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
Jan 12, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Carmol Hc1% · cream;topical	Hydrocortisone Acetate	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Feb 27, 1992	Supplement 18Labeling	Approved	None posted
Nov 23, 1990	Supplement 17Manufacturing	Approved	None posted
Feb 5, 1990	Supplement 16Manufacturing	Approved	None posted
Jan 12, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80505
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

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