Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019834
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PLENDIL FELODIPINE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
PLENDIL FELODIPINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
PLENDIL FELODIPINE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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

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