Orange Book product

NAPROXEN SODIUM 220MG

Orange Book ANDA 074635 · CONTRACT PHARMACAL CORP · Over the counter

Key facts

Proprietary name NAPROXEN SODIUM
Active ingredients NAPROXEN SODIUM
Strength 220MG
Dosage form TABLET
Route ORAL
Application ANDA074635
Applicant holder CONTRACT PHARMACAL CORP
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 13, 1997

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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