Orange Book product

PRAVASTATIN SODIUM 40MG

Orange Book ANDA 077730 · PLIVA HRVATSKA DOO · Discontinued

Key facts

Proprietary name PRAVASTATIN SODIUM
Active ingredients PRAVASTATIN SODIUM
Strength 40MG
Dosage form TABLET
Route ORAL
Application ANDA077730
Applicant holder PLIVA HRVATSKA DOO
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 21, 2006

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

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

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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