Orange Book product

MYCOSTATIN 100,000 UNITS

Orange Book ANDA 060577 · DELCOR ASSET CORP · Discontinued

Key facts

Proprietary name MYCOSTATIN
Active ingredients NYSTATIN
Strength 100,000 UNITS
Dosage form TABLET
Route VAGINAL
Application ANDA060577
Applicant holder DELCOR ASSET CORP
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 1, 1982

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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