Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077739
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET;ORAL Prescription AB No No
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
09/11/2007 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
09/08/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

03/18/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/18/2013 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/19/2014 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/12/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

02/26/2009 SUPPL-5 Labeling

Label is not available on this site.

09/15/2008 SUPPL-3 Labeling

Label is not available on this site.

09/15/2008 SUPPL-2 Labeling

Label is not available on this site.

METOPROLOL TARTRATE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET;ORAL Prescription No AB 202871 ALEMBIC PHARMS LTD
METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET;ORAL Prescription No AB 077739 AUROBINDO PHARMA
METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET;ORAL Prescription No AB 078459 IPCA LABS LTD
METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET;ORAL Prescription No AB 076704 MYLAN
METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET;ORAL Prescription No AB 200981 RUBICON
METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET;ORAL Prescription No AB 076670 SUN PHARM INDS INC
METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET;ORAL Prescription No AB 208955 YOUNGTECH PHARMS INC

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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