Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206535
Company: ZYDUS PHARMS

Products on ANDA 206535

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 206535

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2021	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 206535

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	218111	HAINAN POLY
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	206535	ZYDUS PHARMS