Drugs@FDA: FDA-Approved Drugs

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PLENDIL FELODIPINE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
PLENDIL FELODIPINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
PLENDIL FELODIPINE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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