Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019898
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAVACHOL PRAVASTATIN SODIUM 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
PRAVACHOL PRAVASTATIN SODIUM 20MG TABLET;ORAL Discontinued None Yes No
PRAVACHOL PRAVASTATIN SODIUM 40MG TABLET;ORAL Discontinued None Yes No
PRAVACHOL PRAVASTATIN SODIUM 80MG TABLET;ORAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/31/2022 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019898s070lbl.pdf
09/25/2020 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019898s069lbl.pdf
07/05/2016 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019898s066lbl.pdf
10/31/2012 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf
10/31/2012 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf
02/28/2012 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s062lbl.pdf
05/18/2011 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019898s061lbl.pdf
02/28/2007 SUPPL-60 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019898s060lbl.pdf
07/06/2005 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019898s058lbl.pdf
09/05/2003 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19898slr054_pravachol_lbl.pdf
10/29/2002 SUPPL-52 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s052lbl.pdf
07/12/2002 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s50lbl.pdf
12/18/2001 SUPPL-46 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s46lbl.pdf
06/15/2001 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s42lbl.pdf

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