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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212252
Company: NOVITIUM PHARMA

Products on ANDA 212252

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACYCLOVIR	ACYCLOVIR	200MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212252

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212252

ACYCLOVIR

SUSPENSION;ORAL; 200MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACYCLOVIR	ACYCLOVIR	200MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	074738	ACTAVIS MID ATLANTIC
ACYCLOVIR	ACYCLOVIR	200MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	216331	AUROBINDO PHARMA
ACYCLOVIR	ACYCLOVIR	200MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	212718	CHARTWELL RX
ACYCLOVIR	ACYCLOVIR	200MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	215669	HETERO LABS LTD III
ACYCLOVIR	ACYCLOVIR	200MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	217393	MSN
ACYCLOVIR	ACYCLOVIR	200MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	212252	NOVITIUM PHARMA
ACYCLOVIR	ACYCLOVIR	200MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	215724	RUBICON

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