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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 076457


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NDA 076457 describes GANCICLOVIR, which is a drug marketed by Ranbaxy Labs Ltd, Am Regent, Custopharm Inc, Endo Operations, Fresenius Kabi Usa, Hikma, Pharmascience Inc, Slate Run Pharma, and Steriscience Speclts, and is included in nine NDAs. Additional details are available on the GANCICLOVIR profile page.

The generic ingredient in GANCICLOVIR is ganciclovir sodium. There are twenty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.
Summary for 076457
Tradename:GANCICLOVIR
Applicant:Ranbaxy Labs Ltd
Ingredient:ganciclovir
Patents:0
Medical Subject Heading (MeSH) Categories for 076457

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength250MG
Approval Date:Jun 27, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength500MG
Approval Date:Jun 27, 2003TE:RLD:No

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