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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218085
Company: HETERO LABS LTD III

Products on ANDA 218085

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPIRONOLACTONE	SPIRONOLACTONE	25MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218085

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218085

SPIRONOLACTONE

SUSPENSION;ORAL; 25MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAROSPIR	SPIRONOLACTONE	25MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	209478	CMP DEV LLC
SPIRONOLACTONE	SPIRONOLACTONE	25MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	215572	AMNEAL
SPIRONOLACTONE	SPIRONOLACTONE	25MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	218085	HETERO LABS LTD III

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