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Last Updated: January 23, 2021

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Details for New Drug Application (NDA): 204204

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NDA 204204 describes GANCICLOVIR SODIUM, which is a drug marketed by Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hainan Poly Pharm, Mylan Labs Ltd, Par Sterile Products, Pharmascience Inc, and West-ward Pharms Int, 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. Seven suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.

Summary for 204204

Tradename:	GANCICLOVIR SODIUM
Applicant:	Hainan Poly Pharm
Ingredient:	ganciclovir sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 204204

Mechanism of Action	DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 204204

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204204	ANDA	Hainan Poly Pharm. Co., Ltd.	14335-030	14335-030-01	10 VIAL in 1 CARTON (14335-030-01) > 10 mL in 1 VIAL
GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204204	ANDA	Hainan Poly Pharm. Co., Ltd.	14335-030	14335-030-25	25 VIAL in 1 CARTON (14335-030-25) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Nov 8, 2018	TE:	AP	RLD:	No

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