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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073288
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
03/25/1994 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
02/19/2013 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

04/09/2010 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

03/16/2009 SUPPL-30 Labeling

Label is not available on this site.

06/11/2008 SUPPL-27 Labeling

Label is not available on this site.

02/14/2008 SUPPL-26 Labeling

Label is not available on this site.

06/21/2007 SUPPL-24 Labeling

Label is not available on this site.

08/05/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2001 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/02/2001 SUPPL-14 Labeling

Label is not available on this site.

04/02/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

08/07/2000 SUPPL-12 Labeling

Label is not available on this site.

06/08/2001 SUPPL-11 Labeling

Label is not available on this site.

06/08/2001 SUPPL-10 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/08/2001 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/17/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1999 SUPPL-5 Labeling

Label is not available on this site.

03/03/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/29/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/03/1997 SUPPL-2 Labeling

Label is not available on this site.

11/13/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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