Orange Book product

UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL

Orange Book ANDA 062901 · PFIZER LABORATORIES DIV PFIZER INC · Discontinued

Key facts

Proprietary name UNASYN
Active ingredients AMPICILLIN SODIUM, SULBACTAM SODIUM
Strength EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA062901
Applicant holder PFIZER LABORATORIES DIV PFIZER INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 23, 1988

At a glance

  • 1–9 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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