Cortrophin-Zinc

NDA 9854, held by Ani Pharms. Corticotropin-Zinc Hydroxide.

As of Nov 13, 2026, NDA 9854 (Cortrophin-Zinc), held by Ani Pharms, was first approved by FDA on Jul 29, 1955, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1955
Review: Priority
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
Jul 29, 1955	Original applicationNew active ingredient · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cortrophin-Zinc40 UNITS/ML · injectable;injection	Corticotropin-Zinc Hydroxide	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Oct 5, 2026	Supplement 13Labeling · Standard review	Approved	Label Letter
Jan 2, 1991	Supplement 12Manufacturing · Priority review	Approved	None posted
Feb 10, 1987	Supplement 11Manufacturing · Priority review	Approved	None posted
Oct 7, 1986	Supplement 10Manufacturing · Priority review	Approved	None posted
May 7, 1986	Supplement 8Labeling	Approved	None posted
Dec 8, 1977	Supplement 7Labeling	Approved	None posted
Jul 29, 1955	Original applicationNew active ingredient · Priority review	Approved	None posted

Identifiers

Application: NDA 9854
Drugs@FDA: Overview at FDA
Company: ANI 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