Cortril

NDA 9176, held by Pfizer Global. Hydrocortisone.

As of Nov 13, 2026, NDA 9176 (Cortril), held by Pfizer Global, was first approved by FDA on May 24, 1972, with 2 approved supplements and 0 published complete response letters.

First approved: May 24, 1972
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 24, 1972	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Cortril1% · ointment;topical	Hydrocortisone	Discontinued
Cortril2.5% · ointment;topical	Hydrocortisone	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 21, 1983	Supplement 7Labeling · Standard review	Approved	None posted
Jun 18, 1979	Supplement 5Labeling · Standard review	Approved	None posted
May 24, 1972	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 9176
Drugs@FDA: Overview at FDA
Company: Pfizer

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