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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019962
Company: TOPROL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPROL-XL METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
TOPROL-XL METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
TOPROL-XL METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
TOPROL-XL METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/01/2022 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019962s049lbl.pdf
01/12/2022 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019962s048lbl.pdf
05/06/2014 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019962s044lbl.pdf
10/31/2012 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019962s43lbl.pdf
03/19/2010 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s041lbl.pdf
01/19/2010 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s042lbl.pdf
02/12/2009 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019962s038lbl.pdf
02/15/2008 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019962s036lbl.pdf
07/18/2007 SUPPL-33 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019962s033lbl.pdf
07/27/2006 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019962s032lbl.pdf
07/27/2006 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019962s032lbl.pdf
02/15/2005 SUPPL-27 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19962s027lbl.pdf
02/05/2001 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_prntlbl.pdf
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