Orange Book product

AMPICILLIN TRIHYDRATE EQ 500MG BASE

Orange Book ANDA 064082 · SANDOZ INC · Prescription

Key facts

Proprietary name AMPICILLIN TRIHYDRATE
Active ingredients AMPICILLIN/AMPICILLIN TRIHYDRATE
Strength EQ 500MG BASE
Dosage form CAPSULE
Route ORAL
Application ANDA064082
Applicant holder SANDOZ INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Aug 29, 1995

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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