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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019834
Company: ASTRAZENECA

Products on NDA 019834

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PLENDIL	FELODIPINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
PLENDIL	FELODIPINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
PLENDIL	FELODIPINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019834

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.

Labels for NDA 019834

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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