Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218386
Company: RITEDOSE CORP

Products on ANDA 218386

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218386

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218386

ALBUTEROL SULFATE

SOLUTION;INHALATION; EQ 0.5% 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 0.5% BASE	SOLUTION;INHALATION	Prescription	No	AN	075664	NEPHRON
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION;INHALATION	Prescription	No	AN	218386	RITEDOSE CORP
ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION;INHALATION	Prescription	No	AN	074543	SENTISS