Application Information

This drug has been submitted to the FDA under the reference 076457/001.

Names and composition

"GANCICLOVIR" is the commercial name of a drug composed of GANCICLOVIR.
It belongs to the class CMV treatments and is used in Viral infections (Infections and Infestations)

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
076457/001 GANCICLOVIR GANCICLOVIR CAPSULE/ORAL 250MG
076457/002 GANCICLOVIR GANCICLOVIR CAPSULE/ORAL 500MG
090658/001 GANCICLOVIR GANCICLOVIR SODIUM INJECTABLE/INJECTION EQ 500MG BASE per VIAL
202624/001 GANCICLOVIR GANCICLOVIR SODIUM INJECTABLE/INJECTION EQ 500MG BASE per VIAL
204950/001 GANCICLOVIR GANCICLOVIR SODIUM INJECTABLE/INJECTION EQ 500MG BASE per VIAL
209347/001 GANCICLOVIR GANCICLOVIR SOLUTION/IV (INFUSION) 500MG per 250ML (2MG per ML)

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
020460/001 CYTOVENE GANCICLOVIR CAPSULE/ORAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020460/002 CYTOVENE GANCICLOVIR CAPSULE/ORAL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020569/001 VITRASERT GANCICLOVIR IMPLANT/IMPLANTATION 4.5MG
022211/001 ZIRGAN GANCICLOVIR GEL/OPHTHALMIC 0.15%
076457/001 GANCICLOVIR GANCICLOVIR CAPSULE/ORAL 250MG
076457/002 GANCICLOVIR GANCICLOVIR CAPSULE/ORAL 500MG

Manufacturers

Manufacturer name
Thea Pharmaceuticals Ltd
Roche Products Ltd

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