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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220884
Company: RUBICON RESEARCH

Products on ANDA 220884

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220884

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220884

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 25MG;25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALDACTAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET;ORAL	Prescription	Yes	AB	012616	PFIZER
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET;ORAL	Prescription	No	AB	086513	MYLAN
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET;ORAL	Prescription	No	AB	220884	RUBICON RESEARCH
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET;ORAL	Prescription	No	AB	089534	SUN PHARM INDUSTRIES

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