Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078512
Company: AUROBINDO PHARMA

Products on ANDA 078512

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 078512

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2024	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
05/27/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/18/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/17/2012	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/02/2009	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078512

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