Orange Book product

AMPICILLIN SODIUM EQ 125MG BASE/VIAL

Orange Book ANDA 061395 · SANDOZ INC · Prescription

Key facts

Proprietary name AMPICILLIN SODIUM
Active ingredients AMPICILLIN SODIUM
Strength EQ 125MG BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA061395
Applicant holder SANDOZ INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jan 1, 1982

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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