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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212001

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NDA 212001 describes GANCICLOVIR SODIUM, which is a drug marketed by Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hikma, Onesource Specialty, Ph Health, Pharmascience Inc, and Slate Run Pharma, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the GANCICLOVIR SODIUM profile page.

The generic ingredient in GANCICLOVIR SODIUM 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 212001

Tradename:	GANCICLOVIR SODIUM
Applicant:	Custopharm Inc
Ingredient:	ganciclovir sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jun 20, 2019	TE:		RLD:	No

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