Cyclosporine

ANDA 65025, held by Abbvie. Cyclosporine.

As of Nov 15, 2026, ANDA 65025 (Cyclosporine), held by Abbvie, was first approved by FDA on Mar 3, 2000, with 19 approved supplements and 0 published complete response letters.

First approved: Mar 3, 2000
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Mar 3, 2000	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cyclosporine100MG/ML · solution;oral	Cyclosporine	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Apr 4, 2025	Supplement 27Labeling · Standard review	Approved	None posted
Apr 4, 2025	Supplement 26Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 23Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 21Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 20Labeling · Standard review	Approved	None posted
Feb 6, 2013	Supplement 19Labeling · Standard review	Approved	None posted
Apr 27, 2010	Supplement 16Labeling	Approved	None posted
Dec 9, 2009	Supplement 14Labeling	Approved	None posted
Dec 9, 2009	Supplement 13Labeling	Approved	None posted
Jul 13, 2007	Supplement 12Labeling	Approved	None posted
Feb 26, 2007	Supplement 11Labeling	Approved	None posted
Feb 7, 2007	Supplement 10Labeling	Approved	None posted
Oct 5, 2005	Supplement 6Labeling	Approved	None posted
Sep 1, 2005	Supplement 7Labeling	Approved	None posted
Apr 26, 2004	Supplement 5Labeling	Approved	None posted
Dec 14, 2001	Supplement 4Labeling	Approved	None posted
Aug 15, 2001	Supplement 3Bioequivalence	Approved	None posted
Sep 5, 2000	Supplement 1Manufacturing	Approved	None posted
Aug 9, 2000	Supplement 2Labeling	Approved	None posted
Mar 3, 2000	Original application	Approved	Review Letter

Identifiers

Application: ANDA 65025
Drugs@FDA: Overview at FDA
Company: AbbVie

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