Hydrocortisone

NDA 9659, held by Panray. Hydrocortisone.

As of Nov 13, 2026, NDA 9659 (Hydrocortisone), held by Panray, was first approved by FDA on Jan 19, 1955, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 19, 1955
Review: Standard
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
Jan 19, 1955	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Hydrocortisone10MG · tablet;oral	Hydrocortisone	Discontinued
Hydrocortisone20MG · tablet;oral	Hydrocortisone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 9, 1977	Supplement 3Labeling	Approved	None posted
Jan 19, 1955	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 9659
Drugs@FDA: Overview at FDA
Company: Panray

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