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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211397
Company: VIRTUS PHARM

Products on ANDA 211397

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET;ORAL	Prescription	AB	No	No
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211397

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211397

ALBUTEROL SULFATE

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	208804	AMNEAL PHARMS CO
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	072894	DASH PHARMS NATCO
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	207046	RISING
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	072637	SUN PHARM INDUSTRIES
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	211397	VIRTUS PHARM
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	208884	ZYDUS PHARMS

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	208804	AMNEAL PHARMS CO
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	072894	DASH PHARMS NATCO
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	207046	RISING
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	072637	SUN PHARM INDUSTRIES
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	211397	VIRTUS PHARM
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	208884	ZYDUS PHARMS

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