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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021268
Company: ABBVIE

Other Important Information from FDA

Products on NDA 021268

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEVETEN HCT	EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE	600MG;12.5MG	TABLET;ORAL	Discontinued	None	No	No
TEVETEN HCT	EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE	600MG;25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021268

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/01/2001	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_Teveten.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/22/2014	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021268s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021268Orig1s019ltr.pdf
09/12/2012	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021268Orig1s018ltr.pdf
01/19/2012	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020738s027,021268s017ltr.pdf
05/19/2011	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021268s015,s016ltr.pdf
05/19/2011	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021268s015,s016ltr.pdf
07/11/2005	SUPPL-9	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021268s009ltr.pdf
07/07/2003	SUPPL-6	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21268scm006ltr.pdf
10/16/2003	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20738slr012,21268slr002ltr.pdf
09/27/2002	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021268

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/22/2014	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021268s019lbl.pdf
09/12/2012	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s018lbl.pdf
01/19/2012	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021268s017lbl.pdf
05/19/2011	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf
05/19/2011	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021268s015s016lbl.pdf
11/01/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-268_TEVETEN_prntlbl.pdf

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