Cyclosporine

ANDA 65151, held by Padagis US. Cyclosporine.

As of Nov 15, 2026, ANDA 65151 (Cyclosporine), held by Padagis US, was first approved by FDA on Oct 7, 2003, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 7, 2003
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 7, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cyclosporine50MG/ML · injectable;injection	Cyclosporine	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 30, 2015	Supplement 10Labeling	Approved	None posted
Jun 30, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Jan 31, 2012	Supplement 9Labeling	Approved	None posted
Oct 10, 2006	Supplement 4Labeling	Approved	None posted
Jun 24, 2005	Supplement 3Labeling	Approved	None posted
Oct 7, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 65151
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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