Treats CMV retinitis. ANDA 201276, held by Mylan Institutional. Cidofovir.
As of Nov 15, 2026, ANDA 201276 (Cidofovir), held by Mylan Institutional, was first approved by FDA on Jun 27, 2012, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cidofovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CidofovirEQ 375MG BASE/5ML (EQ 75MG BASE/ML) · solution;intravenous | Cidofovir | Rx |
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
