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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 204560

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NDA 204560 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 Speclts, 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 204560

Tradename:	GANCICLOVIR SODIUM
Applicant:	Steriscience Speclts
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:	Nov 17, 2017	TE:		RLD:	No

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