Orange Book product

SODIUM BUTABARBITAL 15MG

Orange Book ANDA 083484 · IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA · Discontinued

Key facts

Proprietary name SODIUM BUTABARBITAL
Active ingredients BUTABARBITAL SODIUM
Strength 15MG
Dosage form TABLET
Route ORAL
Application ANDA083484
Applicant holder IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 1, 1982

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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