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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021387
Company: BRISTOL MYERS SQUIBB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM 81MG;20MG TABLET;ORAL Discontinued None No No
PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM 81MG;40MG TABLET;ORAL Discontinued None No No
PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM 81MG;80MG TABLET;ORAL Discontinued None No No
PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM 325MG;20MG TABLET;ORAL Discontinued None No No
PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM 325MG;40MG TABLET;ORAL Discontinued None No No
PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM 325MG;80MG TABLET;ORAL Discontinued None No 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
06/24/2003 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21387_pravigard_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21387ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-387_Pravagard.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/24/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21387_pravigard_lbl.pdf
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