Proctocort, Dermacort

ANDA 83011, held by Monarch Pharms. Hydrocortisone.

As of Nov 14, 2026, ANDA 83011 (Proctocort, Dermacort), held by Monarch Pharms, was first approved by FDA on Apr 26, 1973, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 26, 1973
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
Apr 26, 1973	Original application	Approved	None posted

Products

2 strengths and forms


Proctocort1% · cream;topical	Hydrocortisone	Discontinued
Dermacort1% · cream;topical	Hydrocortisone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 8, 1992	Supplement 27Labeling	Approved	None posted
Apr 26, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 83011
Drugs@FDA: Overview at FDA
Company: Monarch Pharmaceuticals

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