Orange Book product

ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML

Orange Book ANDA 211204 · AMNEAL PHARMACEUTICALS OF NEW YORK LLC · Prescription

Key facts

Proprietary name ERYTHROMYCIN ETHYLSUCCINATE
Active ingredients ERYTHROMYCIN ETHYLSUCCINATE
Strength EQ 400MG BASE/5ML
Dosage form GRANULE
Route ORAL
Application ANDA211204
Applicant holder AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 1, 2019

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)

Browse all Orange Book products