Drugs@FDA: FDA-Approved Drugs
Company: ASTRAZENECA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PLENDIL | FELODIPINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
PLENDIL | FELODIPINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
PLENDIL | FELODIPINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
07/25/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
10/31/2012 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019834Orig1s025ltr.pdf | |
06/07/2004 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19834slr022_plendil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19834slr022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019834_S022_PLENDIL.pdf | |
08/26/2002 | SUPPL-20 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019834_S020_PLENDIL.pdf |
09/26/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019834_S019_PLENDIL.pdf |
05/22/2002 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19834s17lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19834S017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019834_017_PLENDIL.pdf | |
11/23/1999 | SUPPL-16 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019834_016_PLENDIL.pdf |
08/28/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
02/08/2000 | SUPPL-14 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019834_s014_PLENDIL.pdf |
07/14/1998 | SUPPL-13 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019834_s013.pdf |
08/07/1997 | SUPPL-12 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019834_s012_PLENDIL.pdf |
10/23/1997 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/13/1998 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19834S009_PLENDIL_PRNTLBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19834S009_PLENDIL_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019834S009_plendil_toc.cfm | |
12/12/1996 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/29/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019834_s007_PLENDIL.pdf |
07/03/1996 | SUPPL-6 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019834_s006_PLENDIL.pdf |
02/05/1996 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019834_s005_PLENDIL.pdf |
07/14/1995 | SUPPL-4 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019834_S004_PLENDIL.pdf |
09/22/1994 | SUPPL-2 | Efficacy-New Dosing Regimen |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019834S002_plendil_toc.cfm |
09/22/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/31/2012 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf | |
06/07/2004 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19834slr022_plendil_lbl.pdf | |
05/22/2002 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19834s17lbl.pdf | |
01/13/1998 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19834S009_PLENDIL_PRNTLBL.PDF |