Treats acquired immunodeficiency syndrome (AIDS). ANDA 204950, held by Ph Health. Ganciclovir Sodium.
As of Nov 15, 2026, ANDA 204950 (Ganciclovir Sodium), held by Ph Health, was first approved by FDA on Dec 6, 2016, with 1 approved supplement and 0 published complete response letters.
Ganciclovir is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). prevention of CMV disease in adult transplant recipients at risk for CMV disease. 1.1 Treatment of CMV Retinitis Ganciclovir is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 6, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ganciclovir SodiumEQ 500MG BASE/VIAL · injectable;injection | Ganciclovir Sodium | Rx |
| Jun 8, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 6, 2016 | Original application | Approved | None posted |
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
