Orange Book product

HYDROCORTISONE VALERATE 0.2%

Orange Book ANDA 210307 · LUPIN LTD · Prescription

Key facts

Proprietary name HYDROCORTISONE VALERATE
Active ingredients HYDROCORTISONE VALERATE
Strength 0.2%
Dosage form CREAM
Route TOPICAL
Application ANDA210307
Applicant holder LUPIN LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 15, 2019

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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