Texacort

ANDA 80425, held by Mission Pharma. Hydrocortisone.

As of Nov 13, 2026, ANDA 80425 (Texacort), held by Mission Pharma, was first approved by FDA on Dec 22, 1971, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1971
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 22, 1971	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Texacort1% · solution;topical	Hydrocortisone	Discontinued

All 7 submissions, including labeling and manufacturing supplements


May 19, 1992	Supplement 10Manufacturing	Approved	None posted
May 19, 1992	Supplement 11Manufacturing	Approved	None posted
Sep 6, 1990	Supplement 12Labeling	Approved	None posted
Oct 12, 1989	Supplement 7Manufacturing	Approved	None posted
Oct 12, 1989	Supplement 8Manufacturing	Approved	None posted
Oct 12, 1989	Supplement 9Labeling	Approved	None posted
Dec 22, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 80425
Drugs@FDA: Overview at FDA
Company: Mission Pharma

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