Orange Book product

TRIAMCINOLONE ACETONIDE 0.1%

Orange Book ANDA 209828 · MACLEODS PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name TRIAMCINOLONE ACETONIDE
Active ingredients TRIAMCINOLONE ACETONIDE
Strength 0.1%
Dosage form OINTMENT
Route TOPICAL
Application ANDA209828
Applicant holder MACLEODS PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 23, 2018

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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