Cyclosporine

Prevents organ rejection in kidney, liver, and heart allogeneic transplants. ANDA 65040, held by Apotex. Cyclosporine.

As of Nov 15, 2026, ANDA 65040 (Cyclosporine), held by Apotex, was first approved by FDA on May 9, 2002, with 6 approved supplements and 0 published complete response letters.

First approved: May 9, 2002
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Cyclosporine capsules, (NON-MODIFIED) are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
May 9, 2002	Original application	Approved	Review Letter

Products

2 strengths and forms


Cyclosporine25MG · capsule;oral	Cyclosporine	Rx
Cyclosporine100MG · capsule;oral	Cyclosporine	Rx

All 7 submissions, including labeling and manufacturing supplements


Aug 1, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Aug 1, 2025	Supplement 20Labeling · Standard review	Approved	None posted
Feb 26, 2014	Supplement 8Labeling	Approved	None posted
Feb 26, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Jun 27, 2006	Supplement 5Labeling	Approved	None posted
May 8, 2006	Supplement 4Labeling	Approved	None posted
May 9, 2002	Original application	Approved	Review Letter

Identifiers

Application: ANDA 65040
Drugs@FDA: Overview at FDA
Company: Apotex

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