Cyclosporine

ANDA 65017, held by Sandoz. Cyclosporine.

As of Nov 15, 2026, ANDA 65017 (Cyclosporine), held by Sandoz, was first approved by FDA on Jan 13, 2000, with 14 approved supplements and 0 published complete response letters.

First approved: Jan 13, 2000
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jan 13, 2000	Original application	Approved	Review Letter Label

Products

2 strengths and forms


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

All 15 submissions, including labeling and manufacturing supplements


Jan 4, 2016	Supplement 22Labeling · Standard review	Approved	None posted
Jan 4, 2016	Supplement 21Manufacturing	Approved	None posted
Jul 8, 2013	Supplement 20Labeling · Standard review	Approved	None posted
Dec 11, 2012	Supplement 15Labeling · Standard review	Approved	None posted
Jan 27, 2012	Supplement 14Labeling	Approved	None posted
Feb 6, 2007	Supplement 11Labeling	Approved	None posted
Apr 19, 2003	Supplement 8Labeling	Approved	None posted
Apr 19, 2002	Supplement 7Manufacturing	Approved	None posted
Dec 6, 2001	Supplement 5Manufacturing	Approved	None posted
Dec 6, 2001	Supplement 4Labeling	Approved	None posted
Sep 7, 2001	Supplement 6Manufacturing	Approved	None posted
May 11, 2000	Supplement 3Manufacturing	Approved	None posted
May 11, 2000	Supplement 2Manufacturing	Approved	None posted
May 11, 2000	Supplement 1Manufacturing	Approved	None posted
Jan 13, 2000	Original application	Approved	Review Letter Label

Identifiers

Application: ANDA 65017
Drugs@FDA: Overview at FDA
Company: Sandoz

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