Orange Book product

ACETOHEXAMIDE 500MG

Orange Book ANDA 071894 · WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC · Discontinued

Key facts

Proprietary name ACETOHEXAMIDE
Active ingredients ACETOHEXAMIDE
Strength 500MG
Dosage form TABLET
Route ORAL
Application ANDA071894
Applicant holder WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 25, 1987

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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