Orange Book product

HYDROCORTISONE AND ACETIC ACID 2%;1%

Orange Book ANDA 040168 · WOCKHARDT EU OPERATIONS (SWISS) AG · Discontinued

Key facts

Proprietary name HYDROCORTISONE AND ACETIC ACID
Active ingredients ACETIC ACID, GLACIAL, HYDROCORTISONE
Strength 2%;1%
Dosage form SOLUTION/DROPS
Route OTIC
Application ANDA040168
Applicant holder WOCKHARDT EU OPERATIONS (SWISS) AG
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 30, 1996

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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