Pravigard Pac (Copackaged)

NDA 21387, held by Bristol Myers Squibb. Aspirin; Pravastatin Sodium.

As of Nov 14, 2026, NDA 21387 (Pravigard Pac (Copackaged)), held by Bristol Myers Squibb, was first approved by FDA on Jun 24, 2003, with 0 approved supplements and 0 published complete response letters.

First approved: Jun 24, 2003
Review: Standard
Supplements approved: 0
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jun 24, 2003	Original applicationNew combination · Standard review	Approved	Review Label Letter

Products

6 strengths and forms


Pravigard Pac (Copackaged)81MG;20MG · tablet;oral	Aspirin; Pravastatin Sodium	Discontinued
Pravigard Pac (Copackaged)81MG;40MG · tablet;oral	Aspirin; Pravastatin Sodium	Discontinued
Pravigard Pac (Copackaged)81MG;80MG · tablet;oral	Aspirin; Pravastatin Sodium	Discontinued
Pravigard Pac (Copackaged)325MG;20MG · tablet;oral	Aspirin; Pravastatin Sodium	Discontinued
Pravigard Pac (Copackaged)325MG;40MG · tablet;oral	Aspirin; Pravastatin Sodium	Discontinued
Pravigard Pac (Copackaged)325MG;80MG · tablet;oral	Aspirin; Pravastatin Sodium	Discontinued

Identifiers

Application: NDA 21387
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters