Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021956
Company: CONCORDIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DUTOPROL HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5MG;EQ 25MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
DUTOPROL HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5MG;EQ 50MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
DUTOPROL HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5MG;EQ 100MG TARTRATE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/28/2006 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021956lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021956s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021956s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/16/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021956s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021956Orig1s010ltr.pdf
06/06/2016 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/02/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/20/2014 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021956s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021956Orig1s004ltr.pdf
12/19/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021956s003ltr.pdf
03/02/2011 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021956s001,s002ltr.pdf
03/02/2011 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021956s001,s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/16/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021956s010lbl.pdf
10/20/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021956s004lbl.pdf
12/19/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s003lbl.pdf
03/02/2011 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s001s002lbl.pdf
03/02/2011 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021956s001s002lbl.pdf
08/28/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021956lbl.pdf

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