Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073654
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET;ORAL Discontinued None No No
METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET;ORAL Discontinued None No No
METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET;ORAL Discontinued None 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
12/21/1993 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
06/22/2015 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

06/22/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

09/20/2011 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

07/15/2009 SUPPL-30 Labeling

Label is not available on this site.

05/09/2007 SUPPL-28 Labeling

Label is not available on this site.

01/06/2003 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/2002 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

03/14/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

10/15/1999 SUPPL-10 Labeling

Label is not available on this site.

03/22/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/18/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/18/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/18/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/18/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/15/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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