Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020668
Company: ASTRAZENECA
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 |