Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019962
Company: ARALEZ PHARMS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/19/2010 ORIG-41 Approval Type 2 - New Active Ingredient STANDARD

Label is not available on this site.

01/10/1992 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/12/2014 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

05/06/2014 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019962s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019962Orig1s044ltr.pdf
10/31/2012 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019962s43lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019962Orig1s043ltr.pdf
01/19/2010 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019962s042ltr.pdf
03/19/2010 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019962s041ltr.pdf
02/12/2009 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019962s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019962s038ltr.pdf
02/15/2008 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019962s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019962s036ltr.pdf
03/14/2007 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019962s034ltr.pdf
07/18/2007 SUPPL-33 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019962s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019962s033ltr.pdf
07/27/2006 SUPPL-32 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019962s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019962s032LTR.pdf
05/04/2006 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019962s031LTR.pdf
04/05/2005 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19962s028ltr.pdf
02/15/2005 SUPPL-27 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19962s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19962s027ltr.pdf
01/27/2003 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19962slr024ltr.pdf
03/05/2002 SUPPL-22 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19962s22ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-962S022.pdf
10/25/2001 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/22/2001 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/12/2001 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/26/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/02/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/22/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/28/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/13/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/05/2001 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol.cfm
03/05/1999 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/25/1996 SUPPL-9 Labeling

Label is not available on this site.

03/11/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1996 SUPPL-7 Labeling

Label is not available on this site.

06/13/1995 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/07/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1994 SUPPL-4 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-004_Toprol_XL.pdf
03/04/1994 SUPPL-3 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-003_Toprol_XL.pdf
06/24/1992 SUPPL-2 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-002_Toprol_XL.pdf
02/27/1992 SUPPL-1 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-001_Toprol_XL.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019962s032lbl.pdf
07/27/2006 SUPPL-32 Labeling-Package Insert 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

TOPROL-XL

TABLET, EXTENDED RELEASE;ORAL; EQ 50MG TARTRATE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204161 ACTAVIS ELIZABETH
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076862 ACTAVIS LABS FL INC
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090617 DR REDDYS LABS LTD
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202033 MYLAN PHARMS INC
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090615 WOCKHARDT
TOPROL-XL METOPROLOL SUCCINATE EQ 50MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019962 ARALEZ PHARMS

TABLET, EXTENDED RELEASE;ORAL; EQ 100MG TARTRATE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204161 ACTAVIS ELIZABETH
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077298 ACTAVIS LABS FL INC
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202033 MYLAN PHARMS INC
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078889 REDDYS
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090615 WOCKHARDT
TOPROL-XL METOPROLOL SUCCINATE EQ 100MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019962 ARALEZ PHARMS

TABLET, EXTENDED RELEASE;ORAL; EQ 200MG TARTRATE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204161 ACTAVIS ELIZABETH
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077298 ACTAVIS LABS FL INC
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202033 MYLAN PHARMS INC
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078889 REDDYS
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090615 WOCKHARDT
TOPROL-XL METOPROLOL SUCCINATE EQ 200MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019962 ARALEZ PHARMS

TABLET, EXTENDED RELEASE;ORAL; EQ 25MG TARTRATE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204161 ACTAVIS ELIZABETH
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077118 ACTAVIS LABS FL INC
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090617 DR REDDYS LABS LTD
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202033 MYLAN PHARMS INC
METOPROLOL SUCCINATE METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090615 WOCKHARDT
TOPROL-XL METOPROLOL SUCCINATE EQ 25MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019962 ARALEZ PHARMS

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