Nogenic Hc

ANDA 87427, held by Ivax Pharms. Hydrocortisone.

As of Nov 13, 2026, ANDA 87427 (Nogenic Hc), held by Ivax Pharms, was first approved by FDA on Apr 4, 1988, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 4, 1988
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
Apr 4, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nogenic Hc1% · cream;topical	Hydrocortisone	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Oct 30, 1992	Supplement 5Labeling	Approved	None posted
Jun 18, 1991	Supplement 2Labeling	Approved	None posted
Apr 5, 1990	Supplement 1Labeling	Approved	None posted
Apr 4, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 87427
Drugs@FDA: Overview at FDA
Company: IVAX 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