Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077839
Company: RITEDOSE CORP

Products on ANDA 077839

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077839

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2008	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
01/28/2013	SUPPL-13	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077839

ALBUTEROL SULFATE

SOLUTION;INHALATION; EQ 0.083% BASE
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION;INHALATION	Prescription	No	AN	206224	LUOXIN AUROVITAS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION;INHALATION	Prescription	No	AN	074880	NEPHRON
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION;INHALATION	Prescription	No	AN	077839	RITEDOSE CORP
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION;INHALATION	Prescription	No	AN	207857	SUN PHARM