Neoral

Prevents organ rejection in kidney, liver, and heart allogeneic transplants. NDA 50715, held by Novartis. Cyclosporine.

As of Nov 13, 2026, NDA 50715 (Neoral), held by Novartis, was first approved by FDA on Jul 14, 1995, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 14, 1995
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Neoral is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jul 14, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Neoral25MG · capsule;oral	Cyclosporine	RxReference drug
Neoral100MG · capsule;oral	Cyclosporine	RxReference drug
Neoral50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Cyclosporine	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Sep 26, 2023	Supplement 41Labeling · Standard review	Approved	Letter Label
Mar 31, 2015	Supplement 35Labeling · Standard review	Approved	Label Letter
May 2, 2013	Supplement 33Labeling · Standard review	Approved	Label Letter
Aug 30, 2012	Supplement 29Labeling · Standard review	Approved	Letter Label
Oct 8, 2009	Supplement 28Labeling	Approved	Letter Label
Sep 24, 2009	Supplement 27Labeling · Standard review	Approved	Letter Label
Aug 1, 2007	Supplement 25Labeling · Standard review	Approved	Letter Label
Mar 6, 2006	Supplement 24Labeling · Standard review	Approved	Letter Label
Jul 19, 2005	Supplement 22Labeling · Standard review	Approved	Label Letter
Feb 6, 2004	Supplement 19Labeling · Standard review	Approved	Letter Label
Feb 6, 2004	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 26, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 12, 2002	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 12, 2002	Supplement 14Labeling · Standard review	Approved	Letter Label
Apr 12, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 16, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 4, 2000	Supplement 7Labeling · Standard review	Approved	None posted
Jun 30, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 21, 1999	Supplement 8Labeling · Standard review	Approved	None posted
Mar 30, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 19, 1997	Supplement 4Labeling · Standard review	Approved	None posted
Oct 11, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 14, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50715
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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