Drug application

PRAVIGARD PAC (COPACKAGED) (ASPIRIN, PRAVASTATIN SODIUM)

Drugs@FDA NDA 021387 · BRISTOL MYERS SQUIBB

Key facts

Drug name PRAVIGARD PAC (COPACKAGED)
Active ingredients ASPIRIN, PRAVASTATIN SODIUM
Application type NDA
Application number 021387
Company BRISTOL MYERS SQUIBB
Dosage forms TABLET, ORAL
Strength 81MG;20MG
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 4 - New Combination
Latest submission status date Jun 24, 2003

At a glance

  • 1–9 Submissions
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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