Orange Book product

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1%

Orange Book ANDA 075673 · TARO PHARMACEUTICAL INDUSTRIES LTD · Prescription

Key facts

Proprietary name CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Active ingredients BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE
Strength EQ 0.05% BASE;1%
Dosage form CREAM
Route TOPICAL
Application ANDA075673
Applicant holder TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 29, 2001

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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