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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213302
Company: UNICHEM

Products on ANDA 213302

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 213302

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/2020	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
03/04/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213302

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	215560	NOVITIUM PHARMA
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET;ORAL	Prescription	No	AB	072302	TWI PHARMS
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
TENORETIC 50	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET;ORAL	Prescription	Yes	AB	018760	TWI 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	215560	NOVITIUM PHARMA
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET;ORAL	Prescription	No	AB	072302	TWI PHARMS
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
TENORETIC 100	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET;ORAL	Prescription	Yes	AB	018760	TWI PHARMS

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