Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090658
Company: FRESENIUS KABI USA

Products on ANDA 090658

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GANCICLOVIR SODIUM	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090658

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/08/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090658

GANCICLOVIR SODIUM

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GANCICLOVIR SODIUM	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090658	FRESENIUS KABI USA
GANCICLOVIR SODIUM	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076222	HIKMA
GANCICLOVIR SODIUM	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204950	PH HEALTH
GANCICLOVIR SODIUM	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207645	PHARMASCIENCE INC
GANCICLOVIR SODIUM	GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204204	SLATE RUN PHARMA