Orange Book product

VOSOL HC 2%;1%

Orange Book NDA 012770 · SAPTALIS PHARMACEUTICALS LLC · Prescription

Key facts

Proprietary name VOSOL HC
Active ingredients ACETIC ACID, GLACIAL, HYDROCORTISONE
Strength 2%;1%
Dosage form SOLUTION/DROPS
Route OTIC
Application NDA012770
Applicant holder SAPTALIS PHARMACEUTICALS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jan 1, 1982

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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