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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 202624

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NDA 202624 describes GANCICLOVIR SODIUM, which is a drug marketed by Am Regent, Custopharm Inc, Endo Operations, Fresenius Kabi Usa, Hikma, Pharmascience Inc, Slate Run Pharma, and Steriscience, 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 202624

Tradename:	GANCICLOVIR SODIUM
Applicant:	Am Regent
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:	Sep 18, 2013	TE:		RLD:	No

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