Application Nr Approved Date Route Status External Links
ANDA076457 2003-06-27 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ganciclovir Capsules Are Indicated For The Prevention Of Cmv Disease In Solid Organ Transplant Recipients And In Individuals With Advanced Hiv Infection At Risk For Developing Cmv Disease. Ganciclovir Capsules Are Also Indicated As An Alternative To The Intravenous Formulation For Maintenance Treatment Of Cmv Retinitis In Immunocompromised Patients, Including Patients With Aids, In Whom Retinitis Is Stable Following Appropriate Induction Therapy And For Whom The Risk Of More Rapid Progression Is Balanced By The Benefit Associated With Avoiding Daily Iv Infusions (see Clinical Trials). Safety And Efficacy Of Ganciclovir Have Not Been Established For Congenital Or Neonatal Cmv Disease; Not For The Treatment Of Established Cmv Disease Other Than Retinitis; Nor For Use In Non-Immunocompromised Individuals. The Safety And Efficacy Of Ganciclovir Capsules Have Not Been Established For Treating Any Manifestation Of Cmv Disease Other Than Maintenance Treatment Of Cmv Retinitis.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Gelatin GELATIN Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
5. Lecithin LECITHIN Unresolved
6. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Povidones POVIDONES Unresolved
9. Shellac SHELLAC Unresolved
10. Simethicone SIMETHICONE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ganciclovir GANCICLOVIR ZINC1505

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