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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215560
Company: NOVITIUM PHARMA

Products on ANDA 215560

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET;ORAL	Prescription	AB	No	No
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215560

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/25/2021	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
09/23/2024	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 215560

ATENOLOL AND CHLORTHALIDONE

TABLET;ORAL; 50MG;25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET;ORAL	Prescription	No	AB	072302	AIPING PHARM INC
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET;ORAL	Prescription	No	AB	215560	NOVITIUM PHARMA
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET;ORAL	Prescription	No	AB	213302	UNICHEM
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET;ORAL	Prescription	No	AB	073665	WATSON LABS
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET;ORAL	Prescription	No	AB	210028	ZYDUS PHARMS

TABLET;ORAL; 100MG;25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET;ORAL	Prescription	No	AB	072302	AIPING PHARM INC
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET;ORAL	Prescription	No	AB	215560	NOVITIUM PHARMA
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET;ORAL	Prescription	No	AB	213302	UNICHEM
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET;ORAL	Prescription	No	AB	073665	WATSON LABS
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET;ORAL	Prescription	No	AB	210028	ZYDUS PHARMS

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