Orange Book product

CLIMARA 0.06MG/24HR

Orange Book NDA 020375 · BAYER HEALTHCARE PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name CLIMARA
Active ingredients ESTRADIOL
Strength 0.06MG/24HR
Dosage form FILM, EXTENDED RELEASE
Route TRANSDERMAL
Application NDA020375
Applicant holder BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB2
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date May 27, 2003

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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