Orange Book product

BACTOCILL EQ 2GM BASE/VIAL **Federal Register determination that…

Orange Book ANDA 061334 · GLAXOSMITHKLINE · Discontinued

Key facts

Proprietary name BACTOCILL
Active ingredients OXACILLIN SODIUM
Strength EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form INJECTABLE
Route INJECTION
Application ANDA061334
Applicant holder GLAXOSMITHKLINE
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 26, 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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