Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020668
Company: ASTRAZENECA
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
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English