Orange Book product

CASPORYN HC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Orange Book NDA 060613 · CASPER PHARMA LLC · Prescription

Key facts

Proprietary name CASPORYN HC
Active ingredients HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Strength 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Dosage form SUSPENSION/DROPS
Route OTIC
Application NDA060613
Applicant holder CASPER PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) Yes
Reference standard (RS) No
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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