Orange Book product

VAGILIA 3.7%;2.86%;3.42%

Orange Book ANDA 088821 · COSETTE PHARMACEUTICALS NC LABORATORIES LLC · Discontinued

Key facts

Proprietary name VAGILIA
Active ingredients TRIPLE SULFA (SULFABENZAMIDE, SULFACETAMIDE, SULFATHIAZOLE)
Strength 3.7%;2.86%;3.42%
Dosage form CREAM
Route VAGINAL
Application ANDA088821
Applicant holder COSETTE PHARMACEUTICALS NC LABORATORIES LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 9, 1987

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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