Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214531
Company: RITEDOSE CORP

Products on ANDA 214531

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION;INHALATION	Prescription	AN	No	Yes
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214531

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/2021	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
05/08/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214531

ALBUTEROL SULFATE

SOLUTION;INHALATION; EQ 0.021% 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 0.021% BASE	SOLUTION;INHALATION	Prescription	No	AN	076355	NEPHRON
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION;INHALATION	Prescription	No	AN	214531	RITEDOSE CORP
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION;INHALATION	Prescription	No	AN	077772	WATSON LABS

SOLUTION;INHALATION; EQ 0.042% 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 0.042% BASE	SOLUTION;INHALATION	Prescription	No	AN	076355	NEPHRON
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION;INHALATION	Prescription	No	AN	214531	RITEDOSE CORP
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION;INHALATION	Prescription	No	AN	077772	WATSON LABS