Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215404
Company: FRESENIUS KABI USA

Products on ANDA 215404

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215404

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215404

ACYCLOVIR SODIUM

INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	203701	EUGIA PHARMA
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	074930	FRESENIUS KABI USA
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	215404	FRESENIUS KABI USA
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	218111	SLATE RUN PHARMA
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	206535	ZYDUS PHARMS