Orange Book product

SULFADIAZINE 500MG

Orange Book ANDA 080081 · IMPAX LABORATORIES INC · Discontinued

Key facts

Proprietary name SULFADIAZINE
Active ingredients SULFADIAZINE
Strength 500MG
Dosage form TABLET
Route ORAL
Application ANDA080081
Applicant holder IMPAX LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jan 1, 1982

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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