Cortrosyn

NDA 16750, held by Amphastar Pharms Inc. Cosyntropin.

As of Nov 13, 2026, NDA 16750 (Cortrosyn), held by Amphastar Pharms Inc, was first approved by FDA on Apr 22, 1970, with 19 approved supplements and 0 published complete response letters.

First approved: Apr 22, 1970
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CORTROSYN is indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Apr 22, 1970	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cortrosyn0.25MG/VIAL · injectable;injection	Cosyntropin	RxReference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 22, 2023	Supplement 33Labeling · Standard review	Approved	Letter Label
Dec 14, 2021	Supplement 32Labeling · Standard review	Approved	Letter Label
Sep 29, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
Nov 5, 2002	Supplement 18Labeling · Standard review	Approved	Letter
Dec 7, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 18, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 9, 1998	Supplement 15Labeling · Standard review	Approved	None posted
Apr 8, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 29, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 28, 1989	Supplement 10Labeling	Approved	None posted
Oct 28, 1988	Supplement 9Manufacturing · Standard review	Approved	None posted
May 9, 1988	Supplement 8Manufacturing · Standard review	Approved	None posted
May 8, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 26, 1987	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 10, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 2, 1986	Supplement 4Labeling	Approved	None posted
Oct 26, 1982	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 28, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 22, 1970	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 16750
Drugs@FDA: Overview at FDA
Company: Amphastar 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