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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019898
Company: BRISTOL MYERS SQUIBB

Products on NDA 19898

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PRAVACHOL	PRAVASTATIN SODIUM	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PRAVACHOL	PRAVASTATIN SODIUM	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PRAVACHOL	PRAVASTATIN SODIUM	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PRAVACHOL	PRAVASTATIN SODIUM	80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 019898

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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