ganciclovir sodium
ganciclovir sodium is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including ganciclovir sodium, ganciclovir, Ganciclovir. Available dosage forms: injection, powder, lyophilized, for solution, injection, solution.
Drug Details
- Generic Name
- ganciclovir sodium
- Brand Names
- ganciclovir sodium, ganciclovir, Ganciclovir
- Application Number
- ANDA204204
- Sponsor
- Slate Run Pharmaceuticals, LLC
- NDC Codes
- 4
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, INJECTION, SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- GANCICLOVIR SODIUM
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 )].