Cyclosporine

ANDA 65054, held by Dr Reddys Labs SA. Cyclosporine.

As of Nov 15, 2026, ANDA 65054 (Cyclosporine), held by Dr Reddys Labs SA, was first approved by FDA on Dec 18, 2001, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 18, 2001
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 18, 2001	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Jan 20, 2015	Supplement 19Labeling · Standard review	Approved	None posted
Nov 16, 2007	Supplement 10Labeling	Approved	None posted
Feb 5, 2007	Supplement 8Labeling	Approved	None posted
Dec 2, 2004	Supplement 4Labeling	Approved	None posted
May 14, 2004	Supplement 3Labeling	Approved	None posted
May 3, 2002	Supplement 1Labeling	Approved	None posted
May 3, 2002	Supplement 2Labeling	Approved	None posted
Dec 18, 2001	Original application	Approved	None posted

Identifiers

Application: ANDA 65054
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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