ganciclovir
ganciclovir is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including ZIRGAN. Available dosage form: gel.
Drug Details
- Generic Name
- ganciclovir
- Brand Names
- ZIRGAN
- Application Number
- NDA022211
- Sponsor
- Bausch & Lomb Incorporated
- NDC Codes
- 1
- Dosage Forms
- GEL
- Routes
- OPHTHALMIC
- Active Ingredients
- GANCICLOVIR
Indications and Usage
1 INDICATIONS AND USAGE Ganciclovir Injection 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). ( 1.1 ) prevention of CMV disease in adult transplant recipients at risk for CMV disease. ( 1.2 ) 1.1 Treatment of CMV Retinitis Ganciclovir Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies ( 14.1 )] . 1.2 Prevention of CMV Disease in Transplant Recipients Ganciclovir Injection is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies ( 14.2 )].