Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074644
Company: SUN PHARM INDS INC

Products on ANDA 074644

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 074644

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/1996	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
10/26/2015	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
10/26/2015	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
02/19/2013	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
02/26/2010	SUPPL-29	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/15/2008	SUPPL-28	Labeling		Label is not available on this site.
03/05/2008	SUPPL-25	Labeling		Label is not available on this site.
06/15/2009	SUPPL-24	Labeling		Label is not available on this site.
09/16/2008	SUPPL-22	Labeling		Label is not available on this site.
11/17/2006	SUPPL-20	Labeling		Label is not available on this site.
03/03/2011	SUPPL-19	Labeling		Label is not available on this site.
03/10/2003	SUPPL-10	Labeling		Label is not available on this site.
10/11/2002	SUPPL-4	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
10/05/2000	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074644

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
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	No	AB	074644	SUN PHARM INDS INC
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Prescription	No	AB	208955	YOUNGTECH PHARMS 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
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	No	AB	074644	SUN PHARM INDS INC
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Prescription	No	AB	208955	YOUNGTECH PHARMS INC