Hydrocortone

NDA 12052, held by Merck. Hydrocortisone Sodium Phosphate.

As of Nov 13, 2026, NDA 12052 (Hydrocortone), held by Merck, was first approved by FDA on Jun 8, 1960, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1960
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Jun 8, 1960	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
HydrocortoneEQ 50MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Hydrocortisone Sodium Phosphate	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Dec 1, 1997	Supplement 51Manufacturing · Standard review	Approved	None posted
May 2, 1997	Supplement 49Manufacturing · Standard review	Approved	None posted
Jan 16, 1997	Supplement 48Manufacturing · Standard review	Approved	None posted
Mar 1, 1996	Supplement 45Manufacturing · Standard review	Approved	None posted
Feb 29, 1996	Supplement 44Manufacturing · Standard review	Approved	None posted
Sep 10, 1993	Supplement 41Manufacturing · Standard review	Approved	None posted
Aug 26, 1993	Supplement 42Labeling · Standard review	Approved	None posted
Sep 6, 1989	Supplement 40Manufacturing · Standard review	Approved	None posted
Jan 15, 1986	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 8, 1985	Supplement 34Labeling · Standard review	Approved	None posted
Feb 23, 1984	Supplement 33Labeling · Standard review	Approved	None posted
Mar 4, 1982	Supplement 28Manufacturing · Standard review	Approved	None posted
Oct 16, 1981	Supplement 29Manufacturing · Standard review	Approved	None posted
Jan 14, 1980	Supplement 27Labeling · Standard review	Approved	None posted
Jun 27, 1977	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 8, 1960	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12052
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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