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Last Updated: December 19, 2025

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, Fresenius Kabi Usa, Hikma, Onesource Specialty, Ph Health, Pharmascience Inc, and Slate Run Pharma, 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

Antiviral Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Jun 27, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Jun 27, 2003	TE:		RLD:	No

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