Orange Book product

BETAMETHASONE VALERATE EQ 0.1% BASE

Orange Book NDA 018865 · FOUGERA PHARMACEUTICALS LLC · Prescription

Key facts

Proprietary name BETAMETHASONE VALERATE
Active ingredients BETAMETHASONE VALERATE
Strength EQ 0.1% BASE
Dosage form OINTMENT
Route TOPICAL
Application NDA018865
Applicant holder FOUGERA PHARMACEUTICALS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Aug 31, 1983

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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