Orange Book product

GRISACTIN ULTRA 165MG

Orange Book ANDA 062438 · WYETH AYERST LABORATORIES · Discontinued

Key facts

Proprietary name GRISACTIN ULTRA
Active ingredients GRISEOFULVIN, ULTRAMICROCRYSTALLINE
Strength 165MG
Dosage form TABLET
Route ORAL
Application ANDA062438
Applicant holder WYETH AYERST LABORATORIES
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 17, 1983

At a glance

  • None 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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