Orange Book product

ERYTHROMYCIN 0.5%

Orange Book ANDA 064067 · BAUSCH AND LOMB INC · Prescription

Key facts

Proprietary name ERYTHROMYCIN
Active ingredients ERYTHROMYCIN
Strength 0.5%
Dosage form OINTMENT
Route OPHTHALMIC
Application ANDA064067
Applicant holder BAUSCH AND LOMB INC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jul 29, 1994

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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