Acth

NDA 8317, held by Parkedale. Corticotropin.

As of Nov 14, 2026, NDA 8317 (Acth), held by Parkedale, was first approved by FDA on Mar 14, 1952, with 8 approved supplements and 0 published complete response letters.

First approved: Mar 14, 1952
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Mar 14, 1952	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Acth25 UNITS/VIAL · injectable;injection	Corticotropin	Discontinued
Acth40 UNITS/VIAL · injectable;injection	Corticotropin	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Nov 12, 2002	Supplement 11Labeling	Approved	None posted
Jul 25, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
May 23, 1990	Supplement 15Labeling	Approved	None posted
Feb 23, 1989	Supplement 13Labeling	Approved	None posted
Jan 19, 1988	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 1, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 8, 1980	Supplement 9Labeling	Approved	None posted
Mar 30, 1978	Supplement 8Labeling	Approved	None posted
Mar 14, 1952	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 8317
Drugs@FDA: Overview at FDA
Company: Parkedale 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