Orange Book product

BARSTATIN 100 100%

Orange Book ANDA 062489 · BARLAN PHARMACAL CO INC · Discontinued

Key facts

Proprietary name BARSTATIN 100
Active ingredients NYSTATIN
Strength 100%
Dosage form POWDER
Route ORAL
Application ANDA062489
Applicant holder BARLAN PHARMACAL CO INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 27, 1988

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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