Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213136
Company: UNICHEM

Products on ANDA 213136

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213136

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2019	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
03/28/2024	SUPPL-12	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213136

ATENOLOL

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Prescription	No	AB	072304	AIPING PHARM INC
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Prescription	No	AB	078512	AUROBINDO PHARMA
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Prescription	No	AB	077877	IPCA LABS LTD
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Prescription	No	AB	073457	MYLAN
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Prescription	No	AB	073026	PHARMOBEDIENT
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Prescription	No	AB	074056	TEVA
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Prescription	No	AB	213136	UNICHEM
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Prescription	No	AB	077443	UNIQUE
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Prescription	No	AB	076900	ZYDUS PHARMS USA
TENORMIN	ATENOLOL	25MG	TABLET;ORAL	Prescription	Yes	AB	018240	TWI PHARMS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATENOLOL	ATENOLOL	50MG	TABLET;ORAL	Prescription	No	AB	072304	AIPING PHARM INC
ATENOLOL	ATENOLOL	50MG	TABLET;ORAL	Prescription	No	AB	078512	AUROBINDO PHARMA
ATENOLOL	ATENOLOL	50MG	TABLET;ORAL	Prescription	No	AB	077877	IPCA LABS LTD
ATENOLOL	ATENOLOL	50MG	TABLET;ORAL	Prescription	No	AB	073457	MYLAN
ATENOLOL	ATENOLOL	50MG	TABLET;ORAL	Prescription	No	AB	073026	PHARMOBEDIENT
ATENOLOL	ATENOLOL	50MG	TABLET;ORAL	Prescription	No	AB	074056	TEVA
ATENOLOL	ATENOLOL	50MG	TABLET;ORAL	Prescription	No	AB	213136	UNICHEM
ATENOLOL	ATENOLOL	50MG	TABLET;ORAL	Prescription	No	AB	077443	UNIQUE
ATENOLOL	ATENOLOL	50MG	TABLET;ORAL	Prescription	No	AB	076900	ZYDUS PHARMS USA
TENORMIN	ATENOLOL	50MG	TABLET;ORAL	Prescription	Yes	AB	018240	TWI PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Prescription	No	AB	072304	AIPING PHARM INC
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Prescription	No	AB	078512	AUROBINDO PHARMA
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Prescription	No	AB	077877	IPCA LABS LTD
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Prescription	No	AB	073457	MYLAN
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Prescription	No	AB	073026	PHARMOBEDIENT
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Prescription	No	AB	074056	TEVA
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Prescription	No	AB	213136	UNICHEM
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Prescription	No	AB	077443	UNIQUE
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Prescription	No	AB	076900	ZYDUS PHARMS USA
TENORMIN	ATENOLOL	100MG	TABLET;ORAL	Prescription	Yes	AB	018240	TWI PHARMS