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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020668
Company: ASTRAZENECA

Products on NDA 020668

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEXXEL	ENALAPRIL MALEATE; FELODIPINE	5MG;5MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
LEXXEL	ENALAPRIL MALEATE; FELODIPINE	5MG;2.5MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020668

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/1996	ORIG-1	Approval	Type 4 - New Combination	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
10/04/2007	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020668s013ltr.pdf
12/23/2004	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20668s012ltr.pdf
06/07/2004	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20668slr011_lexxel_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20668slr011ltr.pdf
06/11/2003	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20668slr009ltr.pdf
09/18/2001	SUPPL-8	Labeling		Label is not available on this site.
02/06/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
07/18/2000	SUPPL-6	Labeling		Label is not available on this site.
08/02/2005	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020668s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020668s005ltr.pdf
07/22/1998	SUPPL-4	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020668_S004_LEXXEL.pdf
10/28/1998	SUPPL-3	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-668S003_Lexxel_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-668S003_Lexxel_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-668s003_Lexxel.cfm
03/03/1998	SUPPL-2	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/020668_S002_Lexxel Tablets.pdf
07/02/1997	SUPPL-1	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020668_S001_Lexxel Tablets.pdf

Labels for NDA 020668

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2005	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020668s005lbl.pdf
06/07/2004	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20668slr011_lexxel_lbl.pdf
10/28/1998	SUPPL-3	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-668S003_Lexxel_prntlbl.pdf

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