Orange Book product

CLOBETASOL PROPIONATE 0.05%

Orange Book ANDA 208779 · TARO PHARMACEUTICAL INDUSTRIES LTD · Prescription

Key facts

Proprietary name CLOBETASOL PROPIONATE
Active ingredients CLOBETASOL PROPIONATE
Strength 0.05%
Dosage form AEROSOL, FOAM
Route TOPICAL
Application ANDA208779
Applicant holder TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB1
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Oct 4, 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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