Orange Book product

AMOXICILLIN 200MG/5ML

Orange Book ANDA 065119 · CHARTWELL RX SCIENCES LLC · Prescription

Key facts

Proprietary name AMOXICILLIN
Active ingredients AMOXICILLIN
Strength 200MG/5ML
Dosage form FOR SUSPENSION
Route ORAL
Application ANDA065119
Applicant holder CHARTWELL RX SCIENCES LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 4, 2002

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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