Orange Book product

TERCONAZOLE 80MG

Orange Book ANDA 077553 · SUN PHARMA CANADA INC · Prescription

Key facts

Proprietary name TERCONAZOLE
Active ingredients TERCONAZOLE
Strength 80MG
Dosage form SUPPOSITORY
Route VAGINAL
Application ANDA077553
Applicant holder SUN PHARMA CANADA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 9, 2007

At a glance

  • 1–9 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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