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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074453
Company: RENATA

Products on ANDA 074453

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074453

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/1995	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
09/03/2025	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/03/2025	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/03/2025	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 074453

METOPROLOL TARTRATE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOPRESSOR	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	Yes	AB	017963	VALIDUS PHARMS
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	No	AB	202871	ALEMBIC PHARMS LTD
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	No	AB	077739	AUROBINDO PHARMA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	No	AB	078459	IPCA LABS LTD
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	No	AB	076704	MYLAN
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	No	AB	074453	RENATA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	No	AB	200981	RUBICON RESEARCH
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	No	AB	208955	SCIEGEN PHARMS
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	No	AB	074644	SUN PHARM INDS INC

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOPRESSOR	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	Yes	AB	017963	VALIDUS PHARMS
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	No	AB	202871	ALEMBIC PHARMS LTD
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	No	AB	077739	AUROBINDO PHARMA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	No	AB	078459	IPCA LABS LTD
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	No	AB	076704	MYLAN
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	No	AB	074453	RENATA
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	No	AB	200981	RUBICON RESEARCH
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	No	AB	208955	SCIEGEN PHARMS
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	No	AB	074644	SUN PHARM INDS INC

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