Drugs@FDA: FDA-Approved Drugs

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

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 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 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

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