Orange Book product

ERYTHROMYCIN 2%

Orange Book ANDA 064127 · RENAISSANCE PHARMA US HOLDINGS INC · Discontinued

Key facts

Proprietary name ERYTHROMYCIN
Active ingredients ERYTHROMYCIN
Strength 2%
Dosage form SOLUTION
Route TOPICAL
Application ANDA064127
Applicant holder RENAISSANCE PHARMA US HOLDINGS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 14, 1997

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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