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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021956
Company: CONCORDIA

Products on NDA 021956

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUTOPROL	HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE	12.5MG;EQ 25MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
DUTOPROL	HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE	12.5MG;EQ 50MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
DUTOPROL	HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE	12.5MG;EQ 100MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021956

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
08/20/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021956s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021956Orig1s012ltr.pdf
01/14/2022	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021956s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021956Orig1s011ltr.pdf
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

Labels for NDA 021956

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/14/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021956s011lbl.pdf
08/20/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021956s012lbl.pdf
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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