Orange Book product

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE EQ 0.05% BASE;1%

Orange Book ANDA 076493 · SUN PHARMA CANADA INC · Prescription

Key facts

Proprietary name CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Active ingredients BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE
Strength EQ 0.05% BASE;1%
Dosage form LOTION
Route TOPICAL
Application ANDA076493
Applicant holder SUN PHARMA CANADA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jul 28, 2004

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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