Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076670
Company: SUN PHARM INDS INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/15/2004 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-18 Labeling-Package Insert

Label is not available on this site.

10/26/2015 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

02/19/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

02/26/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/15/2008 SUPPL-7 Labeling

Label is not available on this site.

03/05/2008 SUPPL-4 Labeling

Label is not available on this site.

06/15/2009 SUPPL-3 Labeling

Label is not available on this site.

11/17/2006 SUPPL-1 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

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