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 |
| 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 |