Orange Book product

SULFACETAMIDE SODIUM 30%

Orange Book ANDA 040216 · EPIC PHARMA LLC · Discontinued

Key facts

Proprietary name SULFACETAMIDE SODIUM
Active ingredients SULFACETAMIDE SODIUM
Strength 30%
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA040216
Applicant holder EPIC PHARMA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 25, 1999

At a glance

  • None 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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